BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4259328 · Received November 12, 2014

    Report

    Report Number
    3008642652-2014-03909
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 13, 2014
    Report Date
    November 11, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    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 EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER MONITOR) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY PACK WAS UNABLE TO RECHARGE OR POWER UP A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A LOOSE SPOT WELD WHERE THE BATTERY CELL CONNECTS TO PAD P4 OF THE BATTERY C/A BOARD. THE ROOT CAUSE FOR THE LOOSE SPOT WELD COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FORM THE BATTERY IMPACTING A HARD SURFACE. NO ADVERSE EVENT RESULTED FROM THE LOOSE SPOT WELD.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED BATTERY PACK SN (B)(4) TO REPORT THAT IT WOULD NOT POWER UP A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728061 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA