BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3150288 · Received May 29, 2013

    Report

    Report Number
    3008642652-2013-01387
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) HAS BEEN CONFIRMED. UPON EVALUATION THE BATTERY CHARGER/MODEM WAS UNABLE TO READ INSERTED BATTERY PACKS DUE TO A SHORTED Q1 CURRENT CONTROLLING TRANSISTOR ON THE BED SIDE BOARD. IN ADDITION THERE WAS CORROSION ON THE BATTERY BOARD. THE ROOT CAUSE FOR THE SHORTED Q1 TRANSISTOR COULD NOT BE POSITIVELY IDENTIFIED. THE ROOT CAUSE FOR THE CORROSION WAS UNABLE TO BE POSITIVELY DETERMINED, BUT WAS LIKELY CONTAMINATION. NO ADVERSE EVENT RESULTED FORM THE SHORTED Q1 TRANSISTOR OR THE CORROSION ON THE BATTERY BOARD. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A TERRITORY MANAGER CALLED ZOLL CUSTOMER TO REPORT THAT A (B)(6) MALE PT'S BATTERY CHARGER WAS BROKEN AND NOT CHARGING HIS BATTERY PACKS. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233686 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR