BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2081740 · Received April 11, 2011

    Report

    Report Number
    3002158293-2011-00395
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    February 17, 2011
    Report Date
    April 7, 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. UPON RECEIPT THE MONITOR WOULD NOT POWER UP. UPON EVAL, IT WAS DISCOVERED THAT MONITOR HAD A DEFECTIVE COMPONENT (C9). (B)(4). THE DEFECTIVE C9 SHORTED THE BATTERY CONNECTOR TO GROUND, BLOWING THE FUSE OF ANY BATTERY PACK INSERTED. THE CAUSE OF THE MONITOR NOT POWERING UP WAS THE FACT THAT THE BATTERIES WERE ALL BLOWN FROM THE DEFECTIVE CAPACITOR. THE ROOT CAUSE OF THE DEFECTIVE CAPACITOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS MOST LIKELY RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CAPACITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT, CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER MONITOR WOULD NOT POWER UP. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR