BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173232 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01488
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 31, 2013
    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) HAS BEEN COMPLETED. UPON EVAL, THE MONITOR'S REAR RESPONSE BUTTON WAS NOT FUNCTIONAL. THE ROOT CAUSE FOR THE FAILURE WAS UNABLE TO BE POSITIVELY DETERMINED BUT WAS LIKELY A DEFECTIVE RESPONSE BUTTON SWITCH. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RESPONSE BUTTON. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, THE REAR RESPONSE BUTTON ON MONITOR SN (B)(4) WAS NOT WORKING. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253536 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA