BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2050193 · Received April 5, 2011

    Report

    Report Number
    3002158293-2011-00365
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    December 18, 2010
    Report Date
    March 26, 2011
    Manufacturer
    ZOLL LIFECOR 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 (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (BATTERY WILL NOT COMMUNICATE) HAS BEEN CONFIRMED. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE LAST PT TO USE THIS BATTERY DID NOT REPORT ANY PROBLEMS WITH IT.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING OF BATTERY PACK (B)(4), WHICH WAS RETURNED FOR ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THE BATTERY PACK WOULD NOT COMMUNICATE WITH THE (B)(4) SOFTWARE. THE LAST PT TO USE THIS BATTERY DID NOT REPORT ANY PROBLEMS WITH IT.

    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 NA