BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061681 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00855
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 27, 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. AS RECEIVED THE MONITOR FAILED INCOMING PULSE TESTING WITH ASSOCIATED CODE 203 - PULSE TEST FAULT. THE CAUSE OF THE PULSE TEST FAULT IS INTERMITTENT CONNECTIONS BETWEEN THE COMPUTER / ANALOG (CA) AND DEFIBRILLATOR BOARDS. THE CAUSE OF THE INTERMITTENT CONNECTIONS IS DEFECTIVE CONNECTORS J1002AA AND J1003AA. THE ROOT CAUSE OF THE DEFECTIVE CONNECTORS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE INTERMITTENT CONNECTIONS. 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) FAILED THE INCOMING PULSE TEST WITH ASSOCIATED SERVICE CODE 203. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129633 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA