BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3172825 · Received May 31, 2013

    Report

    Report Number
    3008642652-2013-01498
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 31, 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 07021070 HAS BEEN COMPLETED. UPON RECEIPT THE MONITOR WAS UNABLE TO DETECT AN ECG WAVEFORM. THE CAUSE OF THE INABILITY TO DETECT WAS A SHORTED -5V BELT NODE POWER SUPPLY. THE CAUSE OF THE SHORTED POWER SUPPLY WAS LIKELY FEEDBACK CAUSED BY BROKEN CONNECTIONS AT THE POSITIVE AND NEGATIVE LEADS OF HIGH VOLTAGE CAPACITOR C19. THE ROOT CAUSE FOR THE BROKEN LEADS 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 ((B)(4)) TO REDUCE THE PCA STRAIN WAS APPROVED BY FDA ON (B)(4) 2012. IMPLEMENTATION BEGAN ON (B)(4) 2013. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FROM THE BROKEN LEADS. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. DURING SERVICING OF MONITOR SN (B)(4), WHICH WAS RETURNED FOR NORMAL MAINTENANCE, THE MONITOR WAS UNABLE TO DETECT AN ECG WAVEFORM. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242211 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA