BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT HT50 VENTILATOR

    MDR report key: 1012110 · Received February 20, 2008

    Report

    Report Number
    2023050-2008-00011
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 16, 2008
    Report Date
    January 29, 2008
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE UNIT HAD BEEN PLUGGED IN FOR 1 1/2 HRS WHEN THE PT HEARD A VERY LOUD (ONE) BEEP. THE CAREGIVER STATES AT THAT MOMENT THE VENT READ 727-0-0; SENSING SOMETHING WAS NOT RIGHT, THE CAREGIVER RETRIEVED THE BACK UP VENT. APPROX ONE MIN LATER, AFTER NOT "BREATHING RIGHT" FOR ABOUT 4 OR 5 BREATHS THE UNIT STOPPED TOTALLY AND GAVE OFF A LOUD, PIERCING CONSTANT BEEP. THE PT WAS QUICKLY SWITCHED TO THE BACK UP VENT. THE UNIT WAS TURNED OFF WHILE STILL PLUGGED IN AND COULD NOT BE TURNED BACK ON. THE ONLY LEDS THAT CAME ON WERE VOLUME CONTROL. PLEASE NOTE THERE WAS NO SERIOUS INJURY OR DEATH IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWPORT HT50 VENTILATOR VENTILATOR CBK FLIGHT MEDICAL LTD. HT50-H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN