BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1913021 · Received November 18, 2010

    Report

    Report Number
    3002158293-2010-01215
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. 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. THE LAST PT TO USE THIS BATTERY DID NOT REPORT ANY DEFICIENCIES. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

    A REVIEW OF SVC DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, BATTERY SN (B)(4) WAS FOUND TO HAVE ONE OR MORE DEFECTIVE CELLS. THE LAST PT TO USE THIS BATTERY DID NOT REPORT ANY DEFICIENCIES.

    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