BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1106697 · Received August 7, 2008

    Report

    Report Number
    3002158293-2008-00351
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 6, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE: MONITOR. ELECTRODE BELT - 05/2008. DEVICE EVAL SUMMARY: DEVICE EVALUATIONS OF MONITOR AND ELECTRODE BELT HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE ELECTRODE BELT HAD AN OPEN DRIVEN GROUND RELAY. THERE WAS NO DRIVEN GROUND SIGNAL BEING APPLIED TO THE BODY. THE OPEN CONNECTION WAS LIKELY DUE TO STRAIN PLACED ON THE CABLE WHICH PULLED THE SOLDER CONNECTION FROM ITS PAD. THIS IS PROBABLY WHY THE PT WAS GETTING "ADJUST BELT" ALARMS. THE MONITOR HAD A SHORTED CAPACITOR BANK. IT ALSO HAD A DAMAGED 5.4 VOLT SUPPLY. THE MONITOR WOULD NOT HAVE TREATED IF NEEDED. THE ROOT CAUSE OF THE DEFECTIVE CAPACITOR BANK IS UNK, BUT IS LIKELY RANDOM COMPONENT FAILURE. THE MONITOR WAS REPAIRED, RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE MONITOR FAILURE. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE PT SERVICE REP (PSR) OF A FEMALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT WAS RECEIVING "ADJUST BELT" MESSAGES. THE PSR SWAPPED ON THE MONITOR AND THEN COULD NOT GET THE DEVICE TO BASELINE. HE THEN SWAPPED OUT THE ELECTRODE BELT THE PSR CONTACTED LIFECOR CUSTOMER SUPPORT AFTER HE EXCHANGED EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR