BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4031106 · Received July 17, 2014

    Report

    Report Number
    3008642652-2014-02215
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ZOLL MANUFACTURING 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 RECEIVED, THE MONITOR FAILED INCOMING TESTING AND DISPLAYED SERVICE CODES 203 AND 102. THE CAUSE FOR THE SERVICE CODES AND INCOMING TEST FAILURE IS AN OPEN RESISTOR R45 ON THE COMPUTER/ANALOG (CA) BOARD. THE CAUSE FOR THE OPEN RESISTOR IS EXCESSIVE CURRENT. THE CAUSE FOR THE EXCESSIVE IS BROKEN LEADS ON HIGH VOLTAGE CAPACITORS C21 AND C22 ON THE DEFIBRILLATOR BOARD. THE ROOT CAUSE FOR THE BROKEN LEADS ON C21 AND C22 COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR IMPACTING A HARD SURFACE, AS THE MONITOR'S CASE WAS RETURNED WITH SIGNS OF DAMAGE. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOUND THAT EXCESSIVE STRAIN ON THE PRINTED CIRCUIT ASSEMBLY (PCA) FROM SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. 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

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. UPON SERVICING MONITOR SN (B)(4), THE MONITOR FAILED INCOMING TESTING AND DISPLAYED SERVICE CODES 203 AND 102. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420689 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA