BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR/OXYGEN ENTRAINMENT MIXER

    MDR report key: 1810587 · Received August 12, 2010

    Report

    Report Number
    3003135857-2010-00012
    Event Type
    Other
    Date Received
    August 12, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 15, 2010
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: EVAL OF THE RETURNED MIXER CONFIRMED THE CUSTOMER REPORT OF USING A MIXER WITH A BROKEN CONNECTOR. VISUAL EXAMINATION OF THE MIXER FOUND THAT THE CONNECTOR IS BROKEN THAT IS USED TO CONNECT TO THE VENTILATOR. ATTACHING THE MIXER TO A VENTILATOR AND VENTILATING AT THE CUSTOMER SETTINGS FOUND THAT THE MIXER DID NOT PASS FIO2 DUE TO THE BROKEN CONNECTOR. AFTER REPAIR OF BROKEN CONNECTOR, THE MIXER WAS TESTED AGAIN AND THE MIXER PASSED ALL TESTS.

    Description of Event or Problem · 1

    REPORTEDLY, WHEN THE PT WAS PLACED ON THE VENTILATOR FOR TRANSPORT, THE PT EXHIBITED LOW O2 (DESATURATION). THE FIO2 WAS INCREASED WITH NO IMPROVEMENT. THE PT WAS PLACED BACK ON THE HOSP VENTILATOR DURING TROUBLESHOOTING OF THE TRANSPORT VENTILATOR. THE RT NOTICED THAT A SMALL LEAK WAS NOTICED AT THE CONNECTION BETWEEN THE MIXER AND THE VENTILATOR DUE TO DAMAGE WHICH DIDN'T ALLOW A COMPLETE SEAL AND ADEQUATE OXYGEN MIXTURE TO THE PT. THE MIXER WAS MANUALLY SECURED BY MODERATE FORCE TO MAINTAIN A SEAL SO THAT THE PT COULD BE TRANSPORTED. NOTE: NO PT INJURY OR MEDICAL INTERVENTION OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR/OXYGEN ENTRAINMENT MIXER CBK FLIGHT MEDICAL LTD. HT460700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention