BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYGEN-AIR BLENDER

    MDR report key: 109568 · Received July 31, 1997

    Report

    Report Number
    1828100-1997-00013
    Event Type
    Injury
    Date Received
    July 31, 1997
    Date of Event
    June 30, 1997
    Report Date
    July 30, 1997
    Manufacturer
    3M HEALTH CARE SARNS AND CDI PRODUCTS
    Product Code
    JRO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE BYPASS PROCEDURE, THE SURGICAL TEAM NOTICED A GRADUAL DROP IN THE PATIENT'S VENOUS OXYGEN SATURATION. USING THE OXYGEN-AIR BLENDER, THEY ATTEMPTED TO RAISE THE SATURATION LEVEL, BUT THEY COULD NOT RAISE THE LEVEL ABOVE 45%. IT HAS SINCE BEEN CONFIRMED THAT THE OXYGEN-AIR BLENDER HAD FAILED TO DELIVER THE SPECIFIED CONCENTRATION OF OXYGEN TO THE PATIENT. THERE HAS BEEN NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN-AIR BLENDER OXYGEN-AIR BLENDER JRO 3M HEALTH CARE SARNS AND CDI PRODUCTS 78-8066-9202-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening