BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1071795 · Received July 7, 2008

    Report

    Report Number
    3002158293-2008-00307
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 14, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE BATTERY CHARGER LED ILLUMINATION WAS A DEFECTIVE U13 8-BIT MICROCONTROLLER WITHIN THE CHARGER. THE ROOT CAUSE OF THE DEFECTIVE U13 CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO A CONTAMINATE WHICH SEEPED INTO THE CONNECTOR AND SHORTED THIS COMPONENT. THE FAULTY CHARGER WAS REPAIRED. IT WAS THEN RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CHARGER. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A FEMALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HER BATTERY PACK WAS NOT CHARGING. SUPPORT HAD RECENTLY REPLACED THIS BATTERY PACK AND DECIDED TO REPLACE THE BATTERY CHARGER.

    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 36 YR