BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3003641 · Received February 12, 2013

    Report

    Report Number
    3008642652-2013-00331
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    December 28, 2012
    Report Date
    February 6, 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 OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS DO NOT ACTIVATE DEVICE) HAS BEEN CONFIRMED. UPON EVAL, REAR RESPONSE BUTTON WAS NOT CONNECTED. THE CAUSE OF THE INABILITY TO ACTIVATE THE DEVICE IS THE DETACHED RESPONSE BUTTON. THE CAUSE OF THE DETACHED RESPONSE BUTTON CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A DEFECTIVE J1005 CONNECTOR. DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER NOT RECOGNIZING BATTERIES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM BEDSIDE AND BATTERY BOARDS WERE CONTAMINATED, WHICH PREVENTED THE CHARGER FROM RECOGNIZING INSERTED BATTERY PACKS. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED CHARGER. THE PT RECEIVED A REPLACEMENT BATTERY/CHARGER MODEM. DEVICE MFR DATE: CHARGER: 06/01/2012.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE RESPONSE BUTTONS WOULD NOT ACTIVATE THE DEVICE. WHEN A ZOLL PATIENT SERVICE REP (PSR) VISITED THE PT TO TROUBLESHOOT, THE PSR ALSO REPORTED THAT THE BATTERY CHARGER/MODEM WAS NOT RECOGNIZING INSERTED BATTERIES. THE PT RECEIVED A REPLACEMENT MONITOR AND CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61993 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR