BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1001309 · Received February 19, 2008

    Report

    Report Number
    3002158293-2008-00064
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 16, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: MONITOR - 11/2003. BATTERY PACK - 09/2007. BATTERY PACK - 09/2007. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF MONITOR AND BATTERY PACKS HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE BATTERY PACK HAD A DAMAGED LOCKING TAB. THE BATTERY PACK WAS REPAIRED. THEN IT WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE DAMAGED CLIP CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO FORCIBLE REMOVAL OF THE BATTERY PACK FROM THE MONITOR WITHOUT PRESSING THE LOCKING TAB BEFORE PULLING. THE OTHER BATTERY PACK AND MONITOR WERE FULL FUNCTIONAL. THEY WERE RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BATTERY PACK. THE PT RECEIVED TWO REPLACEMENT BATTERY PACKS AND A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A FEMALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HER MONITOR HAD UNEXPECTEDLY TURNED OFF SEVERAL TIMES THROUGHOUT THE DAY. SUPPORT ASKED THE PT IF THE BATTERY PACK WAS SECURED INTO THE MONITOR AND SHE STATED IT WAS. THE DOWNLOAD REVEALED NO ABNORMAL SHUTDOWN FLAGS. A LIFECOR PT SERVICES REPRESENTATIVE WAS SENT TO THE PT TO REPLACE THE MONITOR AND BATTERY PACKS.

    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