Events

Rappel de Device Recall P.R.O. Matt

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 Joerns Healthcare.

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
    80113
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2033-2018
  • Date de mise en oeuvre de l'événement
    2018-05-03
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164569
  • 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
    Mattress, flotation therapy, non-powered - Product Code IKY
  • Cause
    Joerns healthcare has identified a potential issue with some of the p.R.O. matt and procair mattresses. for the identified serial number range of p.R.O. matt and procair mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
  • Action
    The firm initiated the recall by letter on 05/04/2018. The letter requested the consignee identify potentially affected mattresses and contact Joerns Healthcare directly to schedule on-site rework of the unit. Distributors were directed to provide the recall information to their accounts.

Device

Device Recall P.R.O. Matt
  • Modèle / numéro de série
    P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA;  Serial Numbers:  1000057154 1000057153  (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA;  Serial Numbers:  1000051430 1000051425 1000051366 1000051422 1000056411 1000058530 1000056414  (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA;  Serial Numbers:  1000049130 1000054638 1000054639  (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA;  Serial Numbers:  1000057195 1000055122 1000055401 1000057190 1000055328 1000054681 1000057193 1000057171 1000051436 1000055326 1000054386 1000054387 1000054385 1000051441 1000051432 1000051439 1000054936 1000054144 1000054935 1000054390 1000054368 1000051440 1000054932 1000055059 1000055134 1000055070 1000055058 1000055118 1000054872 1000055317 1000055130 1000055074 1000055313 1000055093 1000054906 1000055091 1000055132 1000055068 1000054926 1000054922 1000055065 1000054373 1000055062 1000055329 1000054140 1000054868 1000055319 1000054683 1000051437 1000055111 1000049127 1000054927 1000054380 1000054375 1000052270 1000054383 1000054940 1000053404 1000054143 1000054915 1000054917 1000054379 1000054389 1000054924 1000054941 1000055114 1000054378 1000055316 1000054377 1000055337 1000054933 1000051367 1000054371 1000054388 1000052267 1000054142 1000055332 1000057169 1000057860 1000054907  (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA;  Serial Numbers:  PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA  (f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA;  Serial Numbers:  PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA  (g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA;  Serial Numbers:  PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA  (h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT;  Serial Numbers:  PMPE3480SZBADT PMPE3480SZBADT PMPE3480SZBADT
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
  • Description du dispositif
    P.R.O. Matt: || (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA || (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA || (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA || (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA || (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA || (f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA || (g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA || (h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT || Product Usage: || Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).
  • Manufacturer
    Joerns Healthcare

Manufacturer

Joerns Healthcare
  • Adresse du fabricant
    Joerns Healthcare, 2100 Design Rd, Arlington TX 76014-4593
  • Source
    USFDA