BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3223918 · Received July 5, 2013

    Report

    Report Number
    3008642652-2013-01761
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 1, 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 REAR RESPONSE BUTTON WAS MISSING. THE CAUSE FOR THE NON-FUNCTIONAL RESPONSE BUTTON IS MISSING RESPONSE BUTTON SWITCH. THE ROOT CAUSE FOR THE MISSING SWITCH CANNOT BE POSITIVELY IDENTIFIED. BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE MISSING RESPONSE BUTTON. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307139 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA