BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2954276 · Received January 9, 2013

    Report

    Report Number
    3008642652-2013-00103
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 9, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) IS CURRENTLY UNDERWAY. UPON RECEIPT THE MONITOR WOULD RESET AFTER FIRING A PULSE DURING THE PULSE TEST. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. WILL SUBMIT SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NO ADVERSE EVENT RESULTED FROM THE CORRODED COMPONENTS. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. UPON SERVICING OF MONITOR SN (B)(4), THE MONITOR WOULD RESET AFTER FIRING A PULSE DURING THE PULSE TEST. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11333 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA