BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2091417 · Received May 6, 2011

    Report

    Report Number
    3002158293-2011-00519
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    May 5, 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 BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) WAS CONFIRMED. UPON EVAL, THE POWER UNIT WIRE HAD VISIBLE DAMAGE TO THE INSULATION, CAUSING A SHORT IN AN INTERNAL WIRE. THIS SHORT CAUSED THE CHARGER NOT TO POWER ON. THE ROOT CAUSE OF THE DAMAGED INSULATION AND ELECTRICAL SHORT CANNOT BE POSITIVELY DETERMINED, BUT IS LIKELY THE RESULT OF PHYSICAL DAMAGE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER UNIT WIRE. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY CHARGER WILL NO LONGER CHARGE THE PT'S BATTERIES. THE PT WAS ISSUED A REPLACEMENT BATTERY 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 71 YR