BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4321237 · Received December 2, 2014

    Report

    Report Number
    3008642652-2014-04642
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    November 4, 2014
    Report Date
    December 1, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETTING) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY CHARGER/MODEM WOULD NOT POWER ON. THE CAUSE OF THE PROBLEM WAS ISOLATED TO INTERMITTENT U104 (PXA) AND U1003 (PLD) COMPONENTS ON COMPUTER ANALOG (CA) BOARD SN (B)(4). 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. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED BATTERY CHARGER/MODEM SN (B)(4) AND REPORTED THAT THE CHARGER/MODEM WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776351 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTE RDEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA