BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW RANGE FLOWMETER

    MDR report key: 5210377 · Received November 9, 2015

    Report

    Report Number
    5210377
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    August 5, 2014
    Report Date
    November 6, 2015
    Manufacturer
    RESPIRONICS NOVAMETRIX, LLC
    Product Code
    BXY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT IS GETTING OXYGEN EQUIPMENT FROM A HOME CARE MEDICAL AND RESPIRATORY EQUIPMENT PROVIDER. THE PARENTS ARE REPORTING THAT THE HUMIDIFICATION BUBBLE MALFUNCTIONED WHICH CAUSED WATER TO GET INTO THE NASAL CANNULA TUBING AND THEN FROM THERE INTO THE NASAL/ORAL PHARYNX. THIS CAUSED THE PATIENT TO HAVE TO GO TO THE HOSPITAL WHERE SHE PRESENTED WITH HYPOXIA. THE ATTENDING DOCTOR WOULD LIKE TO HAVE THAT EQUIPMENT PICKED UP AND BROUGHT INTO THE HOSPITAL FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742184 LOW RANGE FLOWMETER FLOWMETER, CALIBRATION, GAS BXY RESPIRONICS NOVAMETRIX, LLC KIT NO. 537-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other