BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3192340 · Received June 18, 2013

    Report

    Report Number
    3008642652-2013-01602
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ZOLL LIFECOR CORP
    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 OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED THE MONITOR FAILED INCOMING PULSE TESTING ASSOCIATED CODE 203 - PULSE TEST FAULT AND CODE 102 - CHARGE PROFILE FAULT. THE CAUSE FOR THE CODE 203 AND CODE 102 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 CURRENT. THE CAUSE FOR THE EXCESSIVE CURRENT IS A BROKEN LEAD ON HIGH-VOLTAGE CAPACITOR C21 ON THE DEFIBRILLATOR BOARD. THE ROOT CAUSE FOR THE BROKEN LEAD ON C21 COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR IMPACTING A HARD SURFACE. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOND 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 C21. 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 A PULSE TEST WITH ASSOCIATED CODE 03 - PULSE TEST FAULT AND CODE 102 - CHARGE PROFILE FAULT. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276060 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA