Events

Retiro De Equipo (Recall) de Device Recall Lithium Thionyl nonrechargeable disposable battery pack

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por BRAEMAR, INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    65410
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1652-2013
  • Fecha de inicio del evento
    2012-02-24
  • Fecha de publicación del evento
    2013-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118792
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
  • Descripción del producto
    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.
  • Dirección del fabricante
    BRAEMAR, INC., 1285 Corporate Center Dr, Eagan MN 55121-1267
  • Source
    USFDA