Rappel de Esprit V1000 Ventilator, V200 Ventilator

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Respironics California Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    69313
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0008-2015
  • Date de mise en oeuvre de l'événement
    2014-09-17
  • Date de publication de l'événement
    2014-10-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2016-09-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Ventilator, continuous, facility use - Product Code CBK
  • Cause
    A failure of a specific component may prevent the ventilators from operating on ac power or transitioning back to ac power when operating on battery. additionally, if a battery is not present or is depleted the ventilators will not operate. this failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
  • Action
    Philips Healthcare sent an Urgent - Field Safety Notice dated September 17, 2014, to all customers who purchased the Esprit V1000 and V200 Ventilators to inform them that Respironics is recalling Esprit V1000 and V200 Ventilators installed with 3rd Generation Power Supplies and also 3rd Generation Power Supply Repair Part Kits. The letter identifies the affected devices, informs the customers of the problems, hazard involved, and the actions to be taken. Customers were reminded to be advised of the warnings provided. A Philips Respironics representative will contact customers to schedule a no-cost replacement for further information or support. Customers with questions were instructed to contact Philips Healthcare at 1-800-722-9377. For questions regarding this recall call 760-918-7300.

Device

  • Modèle / numéro de série
    Serial Numbers:  VS0002577 VS0002579 VS0002580 VS0002581 VS0002583 VS0002584 VS0002585 VS0002586 VS0002587 VS0002588 VS0002589 VS0002590 VS0002593 VS0002595 VS0002596 VS0002599 VS0002602 VS0002603 VS0002604 VS0002605 VS0002606 VS0002609 VS0002610 VS0002611 VS0002613 VS0002615 VS0002616 VS0002625 VS0002630 VS0002746 VS0002750 VS0002752 VS0002753 VS0002759 VS0002728 VS0002773 VS0002765 VS0002772 VS0002828 VS0002842 VS0002830 VS0002834 VS0002859 VS0002873 VS0002874 VS0002877 VS0002879 VS0002884 VS0002844 VS0002846 VS0002847 VS0002851 VS0002856 VS0002891 VS0002815 VS0002816 VS0002924 VS0002927 VS0002929 VS0002932 VS0002933 VS0002934 VS0002936 VS0002938 VS0002939 VS0002943 VS0002942 VS0002947 VS0002946 VS0002960 VS0002994 VS0002998 VS0002708 VS0002817 VS0002940 VS0002958 VS0002959 VS0002963 VS0003023 VS0003029 VS0003074 VS0003079 VS0003080 VS0003092 VS0003093 VS0003141 VS0003095 VS0003114 VS0003176 VS0003260 VS0003139 VS0003172 VS0003259 VS0003286 VS0003303 VS0003343 VS0003357 VS0003361 VS0003430 VS0003440 VS0003444 VS0003446 VS0003448 VS0003451 VS0003494 VS0003500 VS0003503 VS0003504 VS0003505 VS0003506 VS0003507 VS0003509 VS0003511 VS0003513 VS0003514 VS0003518 VS0003545 VS0003546 VS0003554 VS0003549 VS0003557 VS0003607 VS0003601 VS0003704 VS0003684 VS0003690 VS0003694 VS0003698 VS0003701 VS0003702 VS0003705 VS0003707 VS0003709 VS0003713 VS0003657 VS0003733 VS0003600 VS0003757 VS0003743 VS0003744 VS0003750 VS0003751 VS0003755 VS0003756 VS0003818 VS0003819 VS0003820 VS0003822 VS0003823 VS0003825 VS0003826 VS0003828 VS0003829 VS0003830 VS0003831 VS0003876 VS0003886 VS0003890 VS0003891 VS0003892 VS0003922 VS0003907 VS0003921 VS0003923 VS0003924 VS0003925 VS0003896 VS0003913 VS0003939 VS0003940 VS0003942 VS0003897 VS0003906 VS0003944 VS0003945 VS0003960 VS0003971 VS0003975 VS0003973 VS0004010 VS0004016 VS0004017 VS0003791 VS0003792 VS0003993 VS0004004 VS0004023 VS0004024 VS0004056 VS0004062 VS0004068 VS0004069 VS0004072 VS0004077 VS0004079 VS0004087 VS0004095 VS0004060 VS0004065 VS0004083 VS0004097 VS0004098 VS0004099 VS0004101 VS0004104 VS0004105 VS0004121 VS0002980 VS0002983 VS3000564 VS3002057 VS3002123 VS3004918 VS3005977 VS3006242 VS3006568 VS3006632 VS3007083 VS3007093 VS3007326 VS3007399 VS3008641 VS3008943 VS3008981 VS3009885 VS3010067 VS3010449 VS3010988 VS3012196 123600002 123600005 123600011 123600018 123600023 123600025 123600029 123600030 123600036 123600039 123600044 123600053 123600056 123600059 123600063 123600077 123600078 123600080 123600081 123600082 123600095 124600102 124600115 124600118 124600157 124600158 124600172 124600179 124600180 124600182 124600183 124600186 124600200 124600201 124600217 124600224 124600225 124600228 124600242 124600247 124600248 124600256 124600257 124600261 124600264 124600266 124600269 124600270 124600278 124600293 124600295 124600296 124600298 124600299 124600301 124600303 124600304 124600306 124600309 124600310 124600312 124600315 124600317 124600321 124600326 124600327 124600329 124600334 124600339 124600343 124600346 124600348 124600354 124600355 124600356 124600358 124600360 124600364 124600373 124600375 124600379 124600381 124600382 124600384 124600386 124600389 124600401 124600410 124600413 124600414 124600430 124600431 124600434 124600440 124600443 124600444 124600446 124600453 124600455 124600457 124600459 124600460 124600463 124600465 124600471 124600476 124600477 124600481 124600483 124600488 124600490 124600491 124600494 124600501 124600502 124600508 124600510 124600512 124600519 124600523 124600525 124600526 124600528 124600529 124600530 124600534 124600535 124600538 124600545 124600546 124600550 124600553 124600555 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Serial Numbers:  VS0002612 VS0002600 VS0002601 VS0002628 VS0002635 VS0002637 VS0002638 VS0002696 VS0002697 VS0002699 VS0002701 VS0002702 VS0002619 VS0002620 VS0002641 VS0002695 VS0002703 VS0002704 VS0002706 VS0002707 VS0002700 VS0002709 VS0002647 VS0002713 VS0002714 VS0002715 VS0002718 VS0002717 VS0002724 VS0002730 VS0002732 VS0002745 VS0002747 VS0002748 VS0002743 VS0002716 VS0002723 VS0002731 VS0002754 VS0002755 VS0002758 VS0002760 VS0002761 VS0002762 VS0002763 VS0002767 VS0002757 VS0002764 VS0002766 VS0002780 VS0002784 VS0002785 VS0002786 VS0002788 VS0002790 VS0002779 VS0002792 VS0002793 VS0002794 VS0002798 VS0002799 VS0002803 VS0002806 VS0002807 VS0002808 VS0002810 VS0002811 VS0002813 VS0002801 VS0002805 VS0002819 VS0002827 VS0002831 VS0002832 VS0002833 VS0002839 VS0002841 VS0002698 VS0002820 VS0002825 VS0002826 VS0002829 VS0002838 VS0002864 VS0002911 VS0002857 VS0002896 VS0002893 VS0002909 VS0002912 VS0002915 VS0002917 VS0002919 VS0002920 VS0002921 VS0002923 VS0002926 VS0002949 VS0002987 VS0002989 VS0002990 VS0002991 VS0002992 VS0002995 VS0002997 VS0002999 VS0003000 VS0003001 VS0003002 VS0003004 VS0002633 VS0002710 VS0002878 VS0002996 VS0003005 VS0003041 VS0003043 VS0002622 VS0002636 VS0002644 VS0002865 VS0003026 VS0003031 VS0003036 VS0003037 VS0003038 VS0003039 VS0003042 VS0003047 VS0003003 VS0003049 VS0002618 VS0002646 VS0003011 VS0003030 VS0003035 VS0003044 VS0003048 VS0003059 VS0003061 VS0003069 VS0002592 VS0003028 VS0003032 VS0003033 VS0003034 VS0003057 VS0003058 VS0003062 VS0003063 VS0003065 VS0003066 VS0003068 VS0003070 VS0003076 VS0003050 VS0003073 VS0003083 VS0003084 VS0003086 VS0003021 VS0003046 VS0003087 VS0003088 VS0003025 VS0003064 VS0003075 VS0003091 VS0003097 VS0003102 VS0003105 VS0003018 VS0003098 VS0003106 VS0003113 VS0003118 VS0003119 VS0003122 VS0003234 VS0003186 VS0003193 VS0003194 VS0003208 VS0003104 VS0003117 VS0003161 VS0003163 VS0003173 VS0003174 VS0003182 VS0003188 VS0003190 VS0003254 VS0003082 VS0003227 VS0003235 VS0003301 VS0003373 VS0003374 VS0003375 VS0003378 VS0003379 VS0003382 VS0003383 VS0003384 VS0003385 VS0003386 VS0003387 VS0003388 VS0003389 VS0003390 VS0003392 VS0003393 VS0003394 VS0003396 VS0003398 VS0003400 VS0003401 VS0003402 VS0003403 VS0003406 VS0003391 VS0003404 VS0003405 VS0003407 VS0003409 VS0003410 VS0003411 VS0003397 VS0003399 VS0003408 VS0003412 VS0003413 VS0003414 VS0003415 VS0003416 VS0003417 VS0003419 VS0003476 VS0003533 VS0003536 VS0003540 VS0003542 VS0003543 VS0003555 VS0003450 VS0003453 VS0003454 VS0003456 VS0003457 VS0003458 VS0003459 VS0003460 VS0003461 VS0003462 VS0003463 VS0003464 VS0003465 VS0003466 VS0003468 VS0003469 VS0003470 VS0003471 VS0003472 VS0003475 VS0003480 VS0003531 VS0003541 VS0003560 VS0003563 VS0003571 VS0003573 VS0003574 VS0003576 VS0003577 VS0003578 VS0003579 VS0003581 VS0003582 VS0003583 VS0003584 VS0003585 VS0003586 VS0003587 VS0003588 VS0003589 VS0003590 VS0003591 VS0003592 VS0003593 VS0003594 VS0003559 VS0003562 VS0003567 VS0003568 VS0003569 VS0003570 VS0003572 VS0003575 VS0003595 VS0003596 VS0003598 VS0003599 VS0003602 VS0003604 VS0003605 VS0003608 VS0003618 VS0003613 VS0003615 VS0003620 VS0003621 VS0003622 VS0003623 VS0003625 VS0003626 VS0003627 VS0003628 VS0003632 VS0003634 VS0003635 VS0003603 VS0003617 VS0003630 VS0003631 VS0003638 VS0003639 VS0003597 VS0003606 VS0003629 VS0003644 VS0003646 VS0003649 VS0003660 VS0003611 VS0003612 VS0003614 VS0003642 VS0003643 VS0003645 VS0003648 VS0003650 VS0003651 VS0003652 VS0003653 VS0003655 VS0003656 VS0003654 VS0003663 VS0003664 VS0003666 VS0003670 VS0003674 VS0003665 VS0003671 VS0003679 VS0003609 VS0003662 VS0003669 VS0003673 VS0003675 VS0003676 VS0003677 VS0003678 VS0003682 VS0003683 VS0003619 VS0003659 VS0003745 VS0003753 VS0003758 VS0003759 VS0003760 VS0003773 VS0003776 VS0003777 VS0003778 VS0003779 VS0003780 VS0003781 VS0003782 VS0003783 VS0003784 VS0003785 VS0003788 VS0003802 VS0003807 VS0003808 VS0003809 VS0003811 VS0003799 VS0003810 VS0003812 VS0003813 VS0003814 VS0003815 VS0003816 VS0003817 VS0003821 VS0003834 VS0003835 VS0003827 VS0003832 VS0003833 VS0003836 VS0003837 VS0003838 VS0003841 VS0003866 VS0003878 VS0003879 VS0003881 VS0003882 VS0003883 VS0003888 VS0003920 VS0003926 VS0003927 VS0003928 VS0003929 VS0003930 VS0003934 VS0003862 VS0003869 VS0003874 VS0003900 VS0003902 VS0003910 VS0003914 VS0003937 VS0003963 VS0003965 VS0003969 VS0003977 VS0003980 VS0003989 VS0003990 VS0003997 VS0004000 VS0004020 VS0004018 VS0003985 VS0003999 VS0004003 VS0004005 VS0004001 VS0004002 VS0003986 VS0003996 VS0004011 VS0004014 VS0004015 VS0004019 VS0004021 VS0004022 VS0004025 VS0004026 VS0004027 VS0004028 VS0004029 VS0004030 VS0004031 VS0004032 VS0004033 VS0004034 VS0004035 VS0004036 VS0004038 VS0004039 VS0004040 VS0003961 VS0003983 VS0003991 VS0004037 VS0004041 VS0004042 VS0004043 VS0004044 VS0004045 VS0004046 VS0004047 VS0004048 VS0004049 VS0004050 VS0004051 VS0004052 VS0004053 VS0004054 VS0004055 VS0004100 VS0004102 VS0004103 VS0004106 VS0004107 VS0004108 VS0004109 VS0004110 VS0004111 VS0004112 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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, Argentina, China, Egypt, Ethiopia, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Jordan, Libyan Arab Yamahiriya, Malaysia, Mali, Mexico, Myanmar (Burma). Nepal, Nigeria. Pakistan, Peru, Philippines, Serbia, Singapore, South Africa, Sri Lanka, United Republic of Tanzania, Thailand, Vietnam, Zimbabwe, Republic of Korea, and Netherlands.
  • Description du dispositif
    Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits || Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92011-1517
  • Société-mère du fabricant (2017)
  • Source
    USFDA