Events

Rappel de LifeVest Wearable Defibrillator

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 Zoll Manufacturing Corp..

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
    78926
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0353-2018
  • Date de mise en oeuvre de l'événement
    2017-09-12
  • 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=160876
  • 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
    Wearable automated external defibrillator - Product Code MVK
  • Cause
    Incorrect service code for properly catching critical defects during self-check. potential for defibrillation shock failure.
  • Action
    On September 14, 2017, ZOLL Manufacturing Corporation issued a patient safety alert notice dated September 12, 2017 to all active patients via courier service. As of November 2, 2017, a copy of this same patient Safety Alert notice is included with all current device shipments. The purpose of the communication is to revise the training patients received about the "Call for service" message. In certain cases, a "Call for service - Message Code 102" could mean that your LifeVest may not be able to deliver therapy if you need it. Users should call ZOLL immediately for a replacement LifeVest if a "Call for service - Message Code 102" appears on the screen. A replacement will be provided within 24 hours. Patients are instructed to continue using the LifeVest as prescribed by their physician.

Device

LifeVest Wearable Defibrillator
  • Modèle / numéro de série
    All Serial Numbers
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide
  • Description du dispositif
    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. || The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
  • Manufacturer
    Zoll Manufacturing Corp.

Manufacturer

Zoll Manufacturing Corp.
  • Adresse du fabricant
    Zoll Manufacturing Corp., 121 Gamma Dr, Pittsburgh PA 15238-2919
  • Société-mère du fabricant (2017)
    Zoll Manufacturing Corporation
  • Source
    USFDA