BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3003729 · Received February 12, 2013

    Report

    Report Number
    3008642652-2013-00374
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 7, 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 CHARGER/MODEM (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) HAS BEEN CONFIRMED. UPON INVESTIGATION THE CHARGER BATTERY BOARD WAS CONTAMINATED, WHICH CAUSED THE REPORTED CHARGER PROBLEM. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED BATTERY BOARD. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER WAS BEEPING THAT THERE WAS A BATTERY CHARGER PROBLEM. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61275 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR