BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXYMATIC MODEL OM-301

    MDR report key: 48495 · Received November 6, 1996

    Report

    Report Number
    2024040-1996-00006
    Event Type
    Other
    Date Received
    November 6, 1996
    Date of Event
    October 14, 1996
    Report Date
    November 5, 1996
    Manufacturer
    CHAD THERAPEUTICS
    Product Code
    CAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    "PT DESATURATED," WHILE USING OXYGEN CONSERVER. FURTHER INVESTIGATION BY CO REVEALED THE PT WAS NOT QUALIFIED FOR THIS DEVICE. HOWEVER, CO HAS NO CONTROL OF THE PRESCRIPTION NOR THE DEALER PT SET UP. CO LABELS (DFU) REFERENCES THE DEVICE QUALIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYMATIC MODEL OM-301 OXYGEN CONSERVER CAN CHAD THERAPEUTICS OXYMATIC OM-301 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other