BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2983314 · Received February 4, 2013

    Report

    Report Number
    3008642652-2013-00304
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 28, 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. AS RECEIVED, THE MONITOR WOULD NOT POWER ON. THE CAUSE OF THE MONITOR NOT POWERING ON WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON C/A BOARD SN (B)(4). THE FLASH MEMORY HAD AN INTERMITTENT BGA CONNECTION AT PIN A25. THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED SOLDER CONNECTION INDUCED BY MECHANICAL STRESS. THE EXACT SOURCE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED BUT THE FRACTURED CONNECTION MAY HAVE BEEN ACCELERATED THROUGH ROUGH HANDLING. 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 (SEE PMA SUPPLEMENT S039) TO REDUCE THE PCA STRAIN WAS APPROVED BY FDA ON 12/20/2012. IMPLEMENTATION IS PLANNED FOR (B)(6) 2013, BASED ON THE AVAILABILITY OF PARTS AND MATERIALS. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE FLASH MEMORY. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, MONITOR SN (B)(4) WAS UNABLE TO POWER UP. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45967 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA