BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2190039 · Received June 29, 2011

    Report

    Report Number
    3008642652-2011-00119
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ZOLL LIFECOR CORP
    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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DEVICE DROPPED) HAS BEEN CONFIRMED. UPON EVALUATION THE MONITOR CASE AND LCD WERE CRACKED, THE END CAP WAS REMOVED FROM THE CASE, SEVERING THE HIGH VOLTAGE WIRES, AND COMPONENTS ON THE COMPUTER ANALOG BOARD AND DEFIBRILLATOR BOARD WERE DAMAGED. THE CAUSE FOR THE EXTENSIVE DAMAGE TO THE MONITOR IS THE MONITOR WAS DROPPED. THE ROOT CAUSE FOR THE DROPPED MONITOR CANNOT BE POSITIVELY DETERMINED AS THE DETAILS OF THE EVENT WERE VAGUE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT SPOKE WITH A (B)(6) FEMALE PT WHO ALLEGED HER DEVICE "BROKE". DURING THE CALL SHE STATES THE "JACKET BROKE" BUT DID NOT CLARIFY THE DETAILS OF THE EVENT. LATER SHE ADMITTED TO "[DROPPING] IT". THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR