BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2243636 · Received July 27, 2011

    Report

    Report Number
    3008642652-2011-00286
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    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 OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO POWER ON) HAS BEEN CONFIRMED. AS RECEIVED, THE UNIT WAS UNABLE TO POWER ON. THE CAUSE FOR THIS WAS DUE TO DEFECTIVE FLASH. ONCE THE FLASH WAS REPROGRAMMED, THE UNIT POWERED UP PROPERLY. THE CAUSE FOR THE FLASH ERRORS CANNOT BE POSITIVELY DETERMINED. DEVICE EVALUATION OF BATTERY PACK SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (DEVICE IS UNABLE TO POWER ON) HAS BEEN CONFIRMED. AS RECEIVED, THE BATTERY PACK HAD AN OUTPUT VOLTAGE OF 3.56 VOLTS. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 05/2011. BATTERY PACK SN (B)(4): 01/2011.

    Description of Event or Problem · 1

    AN (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS SYSTEM IS NOT WORKING. HE STATED THAT HE CHANGED THE BATTERY PACK AND THE SCREEN WENT BLANK. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY PACK AND MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR