BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROCAP PLUS

    MDR report key: 1246203 · Received November 26, 2008

    Report

    Report Number
    8044004-2008-00002
    Event Type
    Death
    Date Received
    November 26, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 25, 2008
    Manufacturer
    ORIDION MEDICAL 1987 LTD
    Product Code
    CCK
    PMA / PMN Number
    024300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS INVESTIGATED WITH THE QUALITY MANAGEMENT UNIT AT THE HOSPITAL, THE FOLLOWING CORRECTIVE AND PREVENTIVE ACTIONS WERE IDENTIFIED AFTER INTERIM ANALYSIS OF CURRENTLY AVAILABLE INFO. HOSPITAL SHALL RETURN DEVICE TO MFR FOR EVALUATION. MFR SHALL PROVIDE EVALUATION REPORT TO HOSPITAL. MFR SHALL WORK WITH HOSPITAL TO PROVIDE TRAINING TO IMPROVE IMPLEMENTATION OF PT MONITORING AND CAPNOGRAPHY IN THIS WARD.

    Description of Event or Problem · 1

    POST SURGERY PT WITH EPIDURAL MONITORED WITH CAPNOGRAPH CONNECTED TO CENTRAL NURSING STATION ON GENERAL FLOOR EXPIRED 4 HOURS AFTER ADMISSION. NURSE CLAIMS THAT MONITOR AND CENTER STATION DID NOT ALARM FOR 30 SECONDS OF NO BREATH OR FOR HIGH END-TIDAL CO2. IN AUTOPSY HIGH CO2 LEVELS WERE IDENTIFIED. EVENT OCCURRED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCAP PLUS CAPNOGRAPH/PULSE OXIMETER CCK ORIDION MEDICAL 1987 LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death