BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT HT50 VENTILATOR

    MDR report key: 765616 · Received November 15, 2005

    Report

    Report Number
    2023050-2005-00054
    Event Type
    Malfunction
    Date Received
    November 15, 2005
    Date of Event
    October 18, 2005
    Report Date
    October 20, 2005
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RECEIVED BY NEWPORT MEDICAL INSTRUMENTS INC. ON 10/25/2005. IT WAS FORWARDED TO MANUFACTURER / FLIGHT MEDICAL LTD. FOR FURTHER INVESTIGATION. A FAILURE ANALYSIS REPORT AND ACTION TAKEN IN RESOLVING THIS ISSUE WILL BE SUBMITTED TO MEDWATCH PROGRAM.

    Description of Event or Problem · 1

    DURING USE ON A PATIENT, THE VENTILATOR GAVE BEEP AND SHUT DOWN BY THE TIME THE FAMILY MEMBER WENT IN THE ROOM TO CHECK THE VENTILATOR. THE FAMILY MEMBER STATED THAT THERE WAS NO 'LOW BATTERY ALARM' PRIOR TO SHUT DOWN. THE VENTILATOR ONLY GAVE AUDIBLE 'EMPTY BATTERY ALARM' THEN SHUT DOWN WITHIN 60 SECONDS. THE FAMILY OWNS THREE NEWPORT HT50 VENTILATORS AND THEY ARE NOT SURE WHICH VENTILATOR WAS INVOLVED IN THE INCIDENT. THERE WAS NO SEVERE INJURY OR NO DEATH REPORTED. THEREFORE, NEWPORT MEDICAL INSTRUMENTS INC. IS REPORTING ALL THREE VENTILATORS WITH THE SAME DESCRIPTION OF EVENT. TWO OTHER VENTILATORS ARE REPORTED UNDER 2023050-2005-00055 AND 2023050-2005-00056.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR