BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2974534 · Received December 21, 2012

    Report

    Report Number
    3008642652-2012-03329
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 17, 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 EVAL SUMMARY; DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM0 WAS CONFIRMED. UPON INVESTIGATION CONTAMINATION WAS DISCOVERED ON THE CHARGER/MODEM¿S BATTERY BOARD. THE ROOT CAUSE FOR THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED BATTERY BOARD. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER/MODEM WOULD NOT STAY POWERED ON. THE PATIENT WAS ISSUED A REPLACEMENT 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 59 YR