BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121044 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00377
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 9, 2008
    Report Date
    August 13, 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 EVALUATION SUMMARY: DEVICE EVALUATIONS FOR 3 BATTERY PACKS HAVE BEEN COMPLETED. THE BATTERY PACK WOULD NOT WORK BECAUSE THERE WAS WATER INSIDE ONE OF THE BATTERY PACK. THE BOARD WAS HEAVILY CORRODED. THE BATTERY PACK WAS SCRAPPED. ONE BATTERY PACK WAS FULLY FUNCTIONAL. IT WAS RETESTED AND RESTOCKED. THE OTHER BATTERY PACK HAD A DAMAGED LOCKING TAB. THE BATTERY PACK WAS REPAIRED. 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. NO ADVERSE EVENT OCCURRED DUE TO THE DEFECTIVE BATTERY PACKS. THE PT REC'D REPLACEMENT BATTERY PACKS.

    Description of Event or Problem · 1

    THE WIFE OF A PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT BOTH BATTERY PACKS WERE DISPLAYING THE SYMBOL WITH THE RED LINE THROUGH IT OVER THE PAST SEVERAL DAYS. SHE STATED THAT WHEN A BATTERY PACK IS PLACED IN THE MONITOR, IT DISPLAYS THE "?". THE PT IS UNABLE TO DOWNLOAD. SUPPORT SENT A PT SERVICES REPRESENTATIVE (PSR) TO THE PT TO REPLACE EQUIPMENT. "SUPPORT DID NOT MANY "BATTERY RUNTIME EXPIRED" ERRORS ON A RECENT DOWNLOAD." THE PSR REPLACED THE PT'S BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR