BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3830437 · Received May 14, 2014

    Report

    Report Number
    3008642652-2014-01438
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 5, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 CHARGING BATTERIES) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE TO RECOGNIZE BATTERY PACKS. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A CONTAMINATED BATTERY BOARD AND A SHORTED U13 CMOS FLASH MICROCONTROLLER ON THE BEDSIDE PCA BOARD. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNK LIQUID. 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

    A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER CHARGER WAS NOT CHARGING HER BATTERIES. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288112 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR