BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2882106 · Received November 12, 2012

    Report

    Report Number
    3008642652-2012-02784
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 7, 2012
    Report Date
    November 5, 2012
    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 EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY PACK NOT CHARGING) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY WOULD NOT CHARGE WHEN PUT INTO THE CHARGER. LIQUID CONTAMINATION WAS FOUND INSIDE THE BATTERY PACK. THE ROOT CAUSE OF THE CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY THE RESULT OF LIQUID INGRESS. DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO CHARGE BATTERIES) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE TO POWER UP. THE CAUSE FOR THE POWER-UP FAILURE WAS ISOLATED TO A DEFECTIVE PXA PROCESSOR (U104) ON THE BATTERY CHARGER C/A BOARD. THE ROOT CAUSE FOR THE DEFECTIVE U104 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK AND DEFECTIVE BATTERY CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK AND CHARGER/MODEM. ADD'L MANUFACTURE DATES: BATTERY PACK SN (B)(4) MANUFACTURED ON 06/01/20011; BATTERY CHARGER/MODEM SN (B)(4) MANUFACTURED ON 03/01/2012.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER BATTERY PACK WOULD NOT CHARGE. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY PACK AND BATTERY CHARGER/MODEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR