BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3090026 · Received April 19, 2013

    Report

    Report Number
    3008642652-2013-01078
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 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. AS REC'D THE MONITOR FAILED INCOMING PULSE TESTING. THE CAUSE FOR THE TEST FAILURE IS DETACHED SOLDER PADS ON HIGH-VOLTAGE CAPACITOR C22 ON THE DEFIBRILLATOR BOARD. THE ROOT CAUSE FOR THE BROKEN LEADS ON C22 COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR IMPACTING A HARD SURFACE. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOUND THAT EXCESSIVE STRAIN ON THE PRINTED CIRCUIT ASSEMBLY (PCA) FROM SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. A MECHANICAL DESIGN CHANGE (SEE PMA SUPPLEMENT S039) TO REDUCE THE PCA STRAIN WAS APPROVED BY FDA ON 12/20/2012. IMPLEMENTATION BEGAN ON 01/21/2013. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FROM THE BROKEN LEADS ON C22. 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) FAILED THE INCOMING PULSE TEST. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169487 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA