BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2221453 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00457
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 9, 2011
    Report Date
    August 15, 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 BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY FAULT) HAS BEEN CONFIRMED. UPON EVAL, THE BATTERY WAS FOUND TO HAVE LOW TRI CELL OUTPUT VOLTAGE READING 0.309V, 0.330V AND 0.345V. THE CAUSE FOR THE LOW OUTPUT VOLTAGES CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A BATTERY PACK WAS RETURNED FROM A (B)(4) DISTRIBUTOR FOR BATTERY FAULTS.

    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 NA