Events

Rappel de Device Recall Xper Flex Cardio

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 Invivo Corporation.

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
    80057
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2115-2018
  • Date de mise en oeuvre de l'événement
    2017-11-20
  • 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=164305
  • 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
    Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
  • Cause
    While in full disclosure playback, a user may inadvertently close the full disclosure control window using the esc key function, instead of pressing the x icon in the upper right corner of this window.
  • Action
    The firm, Philips Healthcare, sent an "URGENT - Medical Device Correction" letter dated November 2017 and Field Safety Notice to each known affected customer. The letter describes the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The customers were instructed to do the following: Follow the Action to be Taken by Customer/User section of the Field Safety Notice as follows: -You may continue to use the device provided that each monitored patient in the Pre or Post-Op Holding Area is closely observed by a qualified health care professional and is not left unattended, as specified in the devices instructions for use. The most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Also, users should always immediately respond to all audible alarms given by the device. Until your device can be corrected, please inform users of the content of this notice and instruct them that to properly exit Full Disclosure playback, use the X icon in the upper right corner of the Full Disclosure Playback control window and do not use the ESC key function. A Philips representative will contact you regarding any affected PCC modules. Each affected PCC will require a software update by Philips. Additionally, all Software and Documentation Media Kits will be replaced. This corrective action will be implemented free of charge by Philips. If you need any further information or support concerning this problem, please contact your local Philips representative: 800-669-1328 option 2, then option 3.

Device

Device Recall Xper Flex Cardio
  • Modèle / numéro de série
    MODEL #(s):  453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801) SERIAL NUMBERS: US1203010251, US1239000027, US1203010279, US1203010280, US1203010308, US1203010334, US1203010346, US1203010352, US1203010358, US1203010360, US1203010366, US1203010375,  US1203010398, US1203010407, US1304000043, US1304000046,  US1224000050, US1550001470, US1251000063, US1109010070,  US1109010072, US1109010075, US1201010130, US1331000013, US1505000507, US1343000034, US1311000042, US1337000033, US1201010112, US1201010119, US1201010120, US1201010122, US1202010171, US1202010186, US1202010202, US1203010396,  US1231000007, US1231000032, US1231000050, US1231000074, US1231000090, US1234000008, US1311000016, US1311000023, US1248000071, US1708000101, US1720000441, US1550001478,  US1248000065, US1729000603, US1352000006, US1352000022, US1352000044, US1352000046, US1352000048, US1107010005,  US1231000060, US1537001268, US1537001272, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea.
  • Description du dispositif
    Xper Flex Cardio Physiomonitoring System || The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • Adresse du fabricant
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA