BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1934515 · Received December 3, 2010

    Report

    Report Number
    3002158293-2010-01288
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 27, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WON'T HOLD CHARGE) HAS BEEN CONFIRMED. UPON EVAL, THE BATTERY WAS FOUND TO HAVE A BENT CONNECTOR PIN. PIN 4 WAS BENT AND PREVENTED THE BATTERY FROM SUCCESSFULLY COMMUNICATING WITH THE CHARGER/MONITOR. THE ROOT CAUSE OF THE BENT PIN CANNOT BE POSITIVELY IDENTIFIED BUT MAY HAVE RESULTED FROM BUMPING OR DROPPING THE PACK ON A HARD SURFACE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT ONE OF HER BATTERIES WILL NOT CHARGE WHEN PLACED ON THE CHARGER. IT WAS ALSO REPORTED THAT THIS BATTERY DOES NOT APPEAR TO BE FULLY SEATED WHILE IN THE CHARGER. SUPPORT ISSUED THE PT A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR