BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1981843 · Received January 10, 2011

    Report

    Report Number
    3002158293-2011-00027
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 25, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVALUATION OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. UPON EVALUATION, THE CONNECTOR WAS DAMAGED AND PIN 4 WAS BENT. THE BATTERY HAD A BROKEN WHITE WIRE OFF ONE OF THE CELLS, CAUSING THE CHARGER FAULT. THE BROKEN WIRE CAUSED AN OPEN CONNECTION BETWEEN THE BATTERY CELLS AND THE PCA BOARD IN THE BATTERY. THE ROOT CAUSE OF THE BROKEN WIRE AND BENT PINS HAS NOT BEEN POSITIVELY DETERMINED BUT MAY HAVE BEEN CAUSED BY A SEVERE SHOCK FROM DROPPING THE PACK. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S DAUGHTER CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT HER FATHER'S CHARGER DISPLAYING "BATTERY FAULT" MESSAGES. THE BATTERY ALSO SHOWED NO CHARGE WHEN INSERTED INTO THE MONITOR. THE PATIENT WAS SENT A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR