BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2961492 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00158
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    November 23, 2012
    Report Date
    January 14, 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 BATTERY PACK SN (B)(4) IS UNDERWAY. THE REPORTED PROBLEM (BATTERY PACK NOT WORKING) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY PACK WAS UNABLE TO RECHARGE OR POWER UP A TEST MONITOR. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ROOT CAUSE INVESTIGATION. DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) HAS BEEN CONFIRMED. UPON INVESTIGATION THE CURRENT CONTROLLING TRANSISTOR Q1 WAS SHORTED AND CONTAMINATION WAS DISCOVERED ON THE BATTERY BOARD. THE ROOT CAUSE FOR THE DAMAGE WAS INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK AND DEFECTIVE BATTERY CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK AND BATTERY CHARGER/MODEM. DEVICE MANUFACTURE DATE: BATTERY PACK SN (B)(4) MANUFACTURED 06/01/2012, BATTERY CHARGER/MODEM SN (B)(4) MANUFACTURED 09/01/2012.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY PACK WASN'T WORKING AND HE HAD A BATTERY CHARGER PROBLEM. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY PACK AND BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28300 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR