BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3812950 · Received April 25, 2014

    Report

    Report Number
    3008642652-2014-01295
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 102) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR FAILED INCOMING TESTING AND DISPLAYED SVC CODE 102. THE CAUSE FOR THE CODE 102 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 CURRENT IS BROKEN SOLDER CONNECTIONS ON HIGH VOLTAGE CAPACITORS C21 AND C22 ON THE DEFIBRILLATOR BOARD. THE ROOT CAUSE FOR THE BROKEN SOLDER CONNECTIONS ON C21 AND 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 ((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 DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONTACTED A (B)(6) FEMALE PT TO EXCHANGE HER MONITOR. THE PT'S DOWNLOADED DATA REVEALED MULTIPLE OCCURRENCES OF SVC CODE 102. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251189 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR