BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT HT50 VENTILATOR

    MDR report key: 765748 · Received November 15, 2005

    Report

    Report Number
    2023050-2005-00057
    Event Type
    Malfunction
    Date Received
    November 15, 2005
    Date of Event
    October 24, 2005
    Report Date
    October 24, 2005
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NEWPORT MEDICAL INSTRUMENTS INC IS CONTACTING THE DEALER IN THE COUNTRY TO OBTAIN DETAIL INFORMATION REGARDING THE INCIDENT. UPON RECEIPT OF INFORMATION, WE WILL SUBMIT IT TO MEDWATCH PROGRAM.

    Description of Event or Problem · 1

    THE USER PULLED THE CORD FROM THE AC POWER SOURCE, AND THE VENTILATOR SHUT DOWN. THERE WAS NO DEATH OR NO SEVERE INJURY REPORTED. NEWPORT MEDICAL INSTRUMENTS INC IS CONTACTING THE DEALER TO OBTAIN DETAIL INFORMATION.

    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 UNKNOWN