BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3940353 · Received April 17, 2014

    Report

    Report Number
    3008642652-2014-01185
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 15, 2014
    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 RESET DURING THE DETECT AND TREAT TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO DEFECTIVE MOSFET DRIVERS (U15, U16, U17, U18) ON THE DEFIBRILLATOR BOARD. THE DEFECTIVE DRIVERS CAUSED THE RESET DURING TESTING. THE ROOT CAUSE FOR THE DEFECTIVE DRIVERS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF THE SERVICE DATA DETECTED A REPORTABLE EVENT. UPON SERVICING, MONITOR SN (B)(4), THE MONITOR RESET DURING THE DETECT AND TREAT TEST. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236059 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA