BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5101382 · Received September 24, 2015

    Report

    Report Number
    3008642652-2015-05860
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 25, 2015
    Report Date
    September 22, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS NON-FUNCTIONAL) WAS CONFIRMED. UPON INVESTIGATION THE REAR RESPONSE BUTTON WAS NON-FUNCTIONAL. THE CAUSE FOR THE DEFECTIVE RESPONSE BUTTON SWITCH WAS AN IMPROPERLY SEATED CONNECTION BETWEEN THE RESPONSE BUTTON CABLE AND CONNECTOR J1005. THE ROOT CAUSE FOR THE DISLODGED RESPONSE BUTTON CONNECTOR WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED MONITOR SN (B)(4) AND REPORTED THAT THE MONITOR RESPONSE BUTTONS WERE NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633251 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1