BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2961713 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00139
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 11, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE REAR RESPONSE BUTTON WAS DEFECTIVE. THE CAUSE FOR THE NON-FUNCTIONAL RESPONSE BUTTON IS DEFECTIVE SWITCH. THE ROOT CAUSE FOR THE DEFECTIVE SWITCH CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RESPONSE BUTTON SWITCH. THE LAST PATIENT 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 DEFECTIVE REAR RESPONSE BUTTON. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28378 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA