BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061682 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00869
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER FAULTS) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE TO CHARGE A BATTERY. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A CONTAMINATED BATTERY PCA BOARD AND A DEFECTIVE U13 CMOS MICRO-CONTROLLER. THE U13 PROCESSOR HAD CORRUPT PROGRAMMING. THE ROOT CAUSE FOR THE CONTAMINATED BATTERY BOARD WAS INGRESS OF AN UNKNOWN LIQUID. THE ROOT CAUSE FOR THE CORRUPT U13 PROGRAMMING COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    DOWNLOAD DATA FROM A (B)(6) MALE PATIENT REVEALED SEVERAL BATTERY CHARGER FAULTS. ZOLL CUSTOMER SUPPORT CONTACTED THE PATIENT AND ISSUED HIM A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130572 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR