BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50 VENTILATOR

    MDR report key: 4151986 · Received July 21, 2014

    Report

    Report Number
    2023050-2014-00313
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 8, 2014
    Manufacturer
    FLIGHT MEDICAL INNOVATION
    Product Code
    NOU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A COVIDIEN SALES REPRESENTATIVE INSPECTED THE DEVICE AND NO ANOMALIES WERE FOUND. ADDITIONALLY, THE CIRCUIT AND OXYGEN BLENDING KIT WAS CHECKED, NO ANOMALIES WERE FOUND. THE DEVICE WAS REPORTED TO BE CONTINUOUSLY USED WITHOUT ISSUE. THERE WAS NO PATIENT HARM REPORTED. THE PATIENT WAS REPORTED TO REMAIN ON THE DEVICE FOR CONTINUOUS VENTILATION. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT ARRIVED TO THE HOSPITAL FOR RESPITE CARE BY TAXI; WHILE BEING VENTILATED ON AN HT50 VENTILATOR. THE HT50 VENTILATOR WAS REPORTED TO HAVE BEEN PLUGGED INTO THE TAXI'S LIGHTER RECEPTACLE FOR THE DURATION OF THE TRIP WHICH WAS REPORTED TO BE ABOUT AN HOUR. UPON ARRIVAL TO THE HOSPITAL THE STAFF NOTICED THE VENTILATOR WAS NOT VENTILATING THE PATIENT. THE STAFF NOTICED THE LIGHT EMITTING DIODE (LED) OF THE EXTERNAL BATTERY WAS ILLUMINATED. THE PATIENT WAS REMOVED FROM THE DEVICE AND AMBU BAGGED DURING TRANSFER FROM THE TAXI TO THE HOSPITAL. ONCE ENTERING THE HOSPITAL THE HT50 WAS REBOOTED AND PLACED BACK ON THE PATIENT. AFTER REMOVING THE PATIENT FROM THE ELEVATOR THE STAFF NOTICED THE VENTILATOR STOPPED CYCLING WITH THE ALARM LED ILLUMINATED. THE VENTILATOR CIRCUITS WERE CHECKED FOR LEAKS HOWEVER NONE WERE FOUND. IN ADDITION, THE MANOMETER WAS FOUND NOT TO BE FUNCTIONING AT THIS TIME. THE PATIENT WAS AGAIN AMBU BAGGED UNTIL A FAMILY MEMBER OF THE PATIENT REBOOTED THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427188 HT50 VENTILATOR CONTINUOUS VENTILATOR NOU FLIGHT MEDICAL INNOVATION HT50

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention