BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3842548 · Received February 21, 2014

    Report

    Report Number
    3008642652-2014-00588
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) WAS COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER DOES NOT RECOGNIZE BATTERIES) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS RESETTING. THE CAUSE FOR THE RESETS WERE ISOLATED TO CORRUPTED DATA IN THE FLASH MEMORY. THE ROOT CAUSE FOR THE CORRUPTED FLASH MEMORY DATA COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    THE DAUGHTER OF A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY CHARGER WAS NOT RECOGNIZING THE BATTERY PACKS. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109572 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR