BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983839 · Received June 20, 2014

    Report

    Report Number
    3008642652-2014-01917
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 19, 2014
    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 BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE BATTERY CHARGER WOULD NOT POWER ON. THE CAUSE OF THE BATTERY CHARGER NOT POWERING ON WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE COMPUTER/ANALOG BOARD. THE FLASH MEMORY HAD AN INTERMITTENT BGA CONNECTION, WHICH WAS DISCOVERED THROUGH THE USE OF A FLASH MEMORY TEST. 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 TO REDUCE THE PCA STRAIN ((B)(4)) WAS APPROVED BY FDA ON (B)(4) 2013. IMPLEMENTATION BEGAN ON (B)(4) 2013. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER/MODEM. THE LAST PATIENT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SVC DATA DETECTED A REPORTABLE EVENT. UPON SVC INVESTIGATION BATTERY CHARGER/MODEM SN (B)(4) WAS UNABLE TO POWER ON. THE LAST PT TO USE THIS DEVICE DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364219 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA