BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2961699 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00179
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 16, 2013
    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 CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER FAULTS) HAS BEEN CONFIRMED. UPON EVAL, THE BATTERY CHARGER¿S POWER SUPPLY WAS DEFECTIVE. THE ROOT CAUSE FOR THE DEFECTIVE POWER SUPPLY WAS UNABLE TO BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER WOULD NOT POWER PROPERLY. THE PATIENT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27616 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR