BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1791144 · Received July 30, 2010

    Report

    Report Number
    3002158293-2010-00790
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    June 25, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DEVICE IS NOT WORKING) HAS BEEN CONFIRMED. UPON INSPECTION, A FOREIGN MATERIAL WAS DISCOVERED AND WAS SHORTING OUT THE AUX BOARD, PREVENTING THE UNIT FROM POWERING UP. THE ROOT CAUSE OF THE FOREIGN MATERIAL IN THE MONITOR CANNOT BE POSITIVELY DETERMINED, BUT WAS LIKELY LIQUID INGRESS THROUGH THE AUXILLIARY PORT CONNECTOR. ONCE THE AUX BOARD WAS REPLACED, THE UNIT HAD POWERED ON NORMALLY. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    DURING THE INVESTIGATION OF AN UNRELATED PROBLEM, ZOLL LIFECOR CUSTOMER SUPPORT CONTACTED THE (B)(6) MALE PT WHO HAD STATED THAT HE HAS NOT BEEN WEARING THE DEVICE BECAUSE "IT HAS NOT WORKED IN TWO MONTHS." 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 CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR