BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983671 · Received June 25, 2014

    Report

    Report Number
    3008642652-2014-01928
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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 (NOT RECOGNIZING BATTERY PACKS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS RESETTING. THE CAUSE FOR THE RESETS WAS ISOLATED TO A SHORTED U13 OMOS FLASH MICROCONTROLLER ON THE BEDSIDE PCA BOARD. THE ROOT CAUSE FOR THE SHORTED U13 COMPONENT 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

    THE WIFE OF A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S CHARGER AS NOT RECOGNIZING INSERTED BATTERY PACKS. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372277 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR