BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLOW SELECTOR VALVE

    MDR report key: 698700 · Received October 4, 2005

    Report

    Report Number
    698700
    Event Type
    Other
    Date Received
    October 4, 2005
    Date of Event
    August 19, 2005
    Report Date
    August 19, 2005
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Product Code
    BXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED AND UNDERWENT OPEN HEART SURGERY. POST-UP, PATIENT WAS ON O2 NASAL CANNULA. PATIENT WAS TRANSFERRED FROM SICU TO N2W. PATIENT ASSISTED TO BED. O2 NASAL CANNULA CONNECTED TO GAUGE WITH TOGGLE SWITCH. THE TOGGLE SWITCH WAS NOTED TO BE IN THE INCORRECT POSITION AND THE O2 WAS NOTED TO BE IN THE INCORRECT POSITION AND THE O2 WAS NOT FLOWING TO THE PATIENT. THE PATIENT'S O2 WAS NOT FLOWING TO THE PATIENT. THE PATIENT'S O2 STATS DROPPED TO 50'S. PATIENT PLACED ON 100% NON-REBREATHER MASK AND TRANSFERRED BACK TO SICU FOR FURTHER TREATMENT. SWITCH IS NOT MARKED AND IS VERY CONFUSING TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW SELECTOR VALVE RESPIRATORY OXYGEN GAUGE VALVE BXY INSTRUMENTATION INDUSTRIES, INC. SC 603-A *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other