BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3003734 · Received February 12, 2013

    Report

    Report Number
    3008642652-2013-00381
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 8, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER NOT WORKING) HAS BEEN CONFIRMED. UPON INVESTIGATION THE CURRENT CONTROLLING TRANSISTOR Q1 WAS SHORTED AND THE CHARGER BATTER BOARD WAS CONTAMINATED. THE ROOT CAUSE FOR THE CONTAMINATION AND SHORTED TRANSISTOR WAS INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED BATTERY BOARD AND SHORTED Q1 TRANSISTOR. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A ZOLL PT SVC REP (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) FEMALE PT'S BATTERY CHARGER/MODEM WAS NOT WORKING. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62200 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR