BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2190037 · Received June 29, 2011

    Report

    Report Number
    3008642652-2011-00113
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 28, 2011
    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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CONNECTOR DAMAGED) HAS BEEN CONFIRMED. UPON EVAL, THE BATTERY CONNECTOR (J1) ON THE DEFIBRILLATOR BOARD WAS FOUND TO BE DAMAGED, PREVENTING THE MONITOR FROM POWERING UP. THE ROOT CAUSE OF THE DAMAGED BATTERY CONNECTOR CANNOT POSITIVELY BE DETERMINED BUT WAS LIKELY DUE TO EXCESSIVE FORCE WHEN THE BATTERY WAS MATED WITH THE MONITOR. NO ADVERSE EVENT RESULTED FROM THE BROKEN BATTERY CONNECTOR. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A PT SVC REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING AN (B)(6) FEMALE PT TO REPORT THAT NEITHER OF THE PT'S BATTERIES WOULD POWER UP HER MONITOR. IT WAS DISCOVERED DURING THE CALL THAT THE MONITOR'S BATTERY CONNECTOR WAS DAMAGED. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR