BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061696 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00864
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 5, 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR WON'T POWER UP) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO BOOT UP PAST THE SPLASH SCREEN. THE CAUSE FOR THE POWER-UP FAILURE WAS ISOLATED TO A DEFECTIVE SD CARD. THE ROOT CAUSE FOR THE DEFECTIVE SD CARD COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE SD CARD. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULDN'T FULLY BOOT UP. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129580 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR