BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPNOSTREAM 20

    MDR report key: 3027442 · Received March 24, 2013

    Report

    Report Number
    MW5029506
    Event Type
    Injury
    Date Received
    March 24, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 24, 2013
    Manufacturer
    ORIDION MEDICAL 1987 LTD
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END TIDAL CO2 MONITOR WITH SMART CAPNOLINE H PLUS O2, MICROSTREAM TUBING # 010433 MFR: ORIDION MEDICAL WAS NOT SENSING RESPIRATIONS AND AS A RESULT THE MONITOR WAS CONSTANTLY ALARMING KEEPING THE PT AWAKE ALL THROUGH THE NIGHT. THE SENSING UNI-JUNCTION ON THE TUBING/CIRCUIT DOES NOT FUNCTION AS INTENDED. THE PT HAD SURGERY ON THE SAME DAY. RECOVERY OF THE PT WAS COMPROMISED. IN ADDITION, THE PT REQUESTED HUMIDIFICATION WITH THE OXYGEN CONNECTED TO THIS CIRCUIT. THE RESPIRATORY THERAPIST STATED THE CIRCUIT CAN NOT BE USED WITH HUMIDIFICATION. THIS WOULD CAUSE AN OCCLUSION IN THE NAFION WATER BARRIER. DOES THIS MEAN THE CIRCUIT/TUBING DOES NOT FUNCTION AS INTENDED? TUBING/CIRCUIT CATALOG #010433, BRAND NAME: SMART CAPNOLINE H PLUS O2, MFR: ORIDION MEDICAL, (B)(6); HEALTH PROFESSIONAL? YES; OCCUPATION: BIOMEDICAL ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121154 CAPNOSTREAM 20 ANALYZER GAS, CARBON DIOXIDE, GASES - PHASE DQA ORIDION MEDICAL 1987 LTD CAPNOSTREAM 20
    121155 MICROSTREAM ANALYZER GAS, CARBON DIOXIDE, GASES-PHASE CCK ORIDION MEDICAL 1987 LTD
    121156 SMART CAPNOLINE H PLUS O2 ANALYZER GAS, CARBON DIOXIDE, GASES-PHASE CCK ORIDION MEDICAL 1987 LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other