BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1961492 · Received January 10, 2011

    Report

    Report Number
    3002158293-2011-00034
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    September 24, 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 EVAL OF THE BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULTS) HAS BEEN CONFIRMED. UPON EVAL, IT WAS DISCOVERED THAT THERE WERE MISMATCHED CELLS WITHIN THE BATTERY PACK, READING 1.28V, 1.04V AND 1.28V. THE ROOT CAUSE OF THE MISMATCHED TRI-CELLS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR RETURNED BATTERY PACK SN (B)(4) TO ZOLL NOTING THAT THE BATTERY IS HEATING UP WHILE ON THE CHARGER.

    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 NA