BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3072323 · Received April 5, 2013

    Report

    Report Number
    3008642652-2013-00911
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 2, 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. UPON INVESTIGATION U1003 (PLD) WAS SHORTED, BY A POWER SURGE TO THE 3.3V AND 1.8V POWER SUPPLIES. THE CAUSE FOR THE SURGE WAS A BROKEN NEGATIVE LEAD ON HIGH-VOLTAGE CAPACITOR C22 ON THE DEFIBRILLATOR BOARD THE ROOT CAUSE FOR THE BROKEN LEAD ON C22 COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGED 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 LEAD ON C22. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    REVIEW OF SVC DATA DETECTED A REPORTABLE EVENT. UPON SERVICING OF MONITOR SN (B)(4) THE MONITOR GENERATED A CODE 202 (PT PARAMETERS CORRUPT) AND FAILED THE PULSE TEST. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142029 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA