BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2220614 · Received July 15, 2011

    Report

    Report Number
    3008642652-2011-00222
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 15, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT CHARGE; BATTERY/CHARGER FAULTS) HAS BEEN CONFIRMED. THE CAUSE OF THE DISCHARGED BATTERY PACK WAS DEFECTIVE CELLS WITHIN THE BATTERY PACK. ONE OR MORE OF THE CELLS HAD RESIDUE/CORROSION ON THEM. THE SOURCE OF THE RESIDUE/CORROSION HAS NOT BEEN POSITIVELY IDENTIFIED BUT IS LIKELY ELECTROLYTE FROM A LEAKING CELL. THE ROOT CAUSE OF THE LEAKING CELL WAS NOT POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CELLS.

    Description of Event or Problem · 1

    A (B)(4) DISTRIBUTOR RETURNED BATTERY (B)(4) TO ZOLL WITH A NOTE STATING THE "BATTERY WAS NOT ABLE TO CHARGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR