Events

Rappel de Device Recall Lithium Thionyl nonrechargeable disposable battery pack

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 BRAEMAR, 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
    65410
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1652-2013
  • Date de mise en oeuvre de l'événement
    2012-02-24
  • Date de publication de l'événement
    2013-07-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118792
  • 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
    Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
  • Cause
    Braemar has recently became aware of a battery related incident that occurred with ewt battery packs that are used in a braemer er920w wireless event monitor and fusion device. the event did not result in any patient related injury or present any clinical impact.
  • Action
    Braemar began notifying customers by telephone on 2/24/2012. Braemar issued Advisory Notice letter P/N 600-066201 RevA on 3/02/2012. The letter described the product, the problem, and the action to be taken by the customer. Customers were requested to only use TESTED batteries that they have receivewd fromBraemar starting on February 23, 2012. Complete and return the attached Verification Form. If customers have any untested product in their inventory, they were instructed to segregate those battery packs and await further instruction from Braemar to coordinate the return of those untested units. Upon receipt of the attached verification form, Braemar will continue to send replacement battery packs that have passed the additional testing protocol. Customers were instructed to contact their Braemar sales representative if they have any questions regarding the notice. For questions regarding this recall call 651-286-8620.

Device

Device Recall Lithium Thionyl nonrechargeable disposable battery pack
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
  • Description du dispositif
    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. || Non-rechargeable disposable battery pack.
  • Manufacturer
    BRAEMAR, INC.

Manufacturer

BRAEMAR, INC.
  • Adresse du fabricant
    BRAEMAR, INC., 1285 Corporate Center Dr, Eagan MN 55121-1267
  • Source
    USFDA