BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1950990 · Received December 31, 2010

    Report

    Report Number
    3002158293-2010-01377
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    October 26, 2010
    Report Date
    December 30, 2010
    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

    BATTERY PACK (B)(4); BATTERY PACK (B)(4): 01/2010. DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEMS (WON'T POWER UP MONITOR/BATTERY CHARGER FAULTS) HAVE BEEN CONFIRMED. THE CAUSE OF THE DISCHARGED BATTERY PACK WAS DEFECTIVE CELLS WITHIN THE BATTERY PACK. ONE OR MORE OF THE CELLS HAD RESIDUE/CORROSION ON THEM. THE SOURCE OF THE RESIDUE/CORROSION HAS NOT BEEN POSITIVELY IDENTIFIED BUT IS LIKELY ELECTROLYTE FROM A LEAKING CELL. THE ROOT CAUSE OF THE LEAKING CELL WAS NOT POSITIVELY IDENTIFIED. DEVICE EVALUATION OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEMS (WON'T POWER UP MONITOR/BATTERY CHARGER FAULTS) HAVE BEEN CONFIRMED. UPON EVALUATION, IT WAS DISCOVERED THAT THE BATTERY PACK HAD ONE OR MORE DEFECTIVE CELLS. THE ROOT CAUSE OF THE DEFECTIVE CELLS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERIES. THE PT RECEIVED REPLACEMENT BATTERIES.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT SERVICE TO REPORT THAT NEITHER OF HIS BATTERIES WOULD POWER UP HIS MONITOR. THE PT WAS PROVIDED A REPLACEMENT MONITOR AND TWO REPLACEMENT BATTERIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR