BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4093070 · Received September 10, 2014

    Report

    Report Number
    3008642652-2014-02782
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP MONITOR) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY PACK WAS UNABLE TO POWER UP A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO EXCESSIVELY DISCHARGED BATTERY CELLS. THE ROOT CAUSE FOR THE EXCESSIVE DISCHARGE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT BATTERY PACK SN (B)(4) WAS UNABLE TO POWER UP A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559852 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA