BEUDAMED
    FDA Adverse Event Other Summary report: N

    MR730 RESPIRATORY HUMIDIFIER HEATER

    MDR report key: 476153 · Received July 28, 2003

    Report

    Report Number
    476153
    Event Type
    Other
    Date Received
    July 28, 2003
    Date of Event
    August 1, 2002
    Report Date
    October 1, 2002
    Manufacturer
    FISHER PAYKEL HEALTHCARE, LTD
    Product Code
    BTT
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATION TUBING WAS FOUND TO BE "QUITE HOT" AT THE CONNECTION TO THE PT. THE HEATER READING WAS 29.5. THE PT WAS REMOVED FROM THE VENTILATOR AND RESPIRATORY THERAPY CALLED TO BEDSIDE. THE PT WAS BAGGED UNTIL THE VENT WAS CHECKED BY THE REPSIRATORY THERAPIST. THE TUBING COOLED, ALL THE CONNECTIONS WERE TIGHTENED AND THE PT WAS RETURNED TO THE VENTILATOR. THE TUBING WAS MANUALLY CHECKED FOR TEMPERATURE EVERY 20 MINUTES THE REST OF THE NIGHT SHIFT. THE TUBING WAS AGAIN FOUND TO BE HOT. THE PT WAS REMOVED FROM THE VENTILATOR AGAIN. A THERMOMETER WAS PLACED IN THE OPENING. THE TEMPERATURE READ 103.7. RESPIRATORY THERAPY WAS CALLED AGAIN. A NEW TEMPERATURE PROBE WAS PLACED ON THE HEATER. NO FURTHER INCIDENTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MR730 RESPIRATORY HUMIDIFIER HEATER VENTILATOR HEATER BTT FISHER PAYKEL HEALTHCARE, LTD MR730 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other