BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL FITTINGS FLOW SELECTOR

    MDR report key: 275930 · Received April 26, 2000

    Report

    Report Number
    2523148-2000-00002
    Event Type
    Malfunction
    Date Received
    April 26, 2000
    Report Date
    April 24, 2000
    Manufacturer
    PRECISION MEDICAL, INC.
    Product Code
    BXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "OXYGEN SPLITTER" DEVICE FAILED TO SWITCH TO APPROPRIATE OUTLET FOR NASAL OXYGEN. SWITCH MECHANISM CAUGHT HALFWAY BETWEEN OUTLETS. PT WAS NOT RECEIVING OXYGEN AS ORDERED. DEVICE AS DESCRIBED BY RPTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL FITTINGS FLOW SELECTOR OXYGEN FLOW SELECTOR BXY PRECISION MEDICAL, INC. MF8025 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention