BEUDAMED
    FDA Adverse Event Death Summary report: N

    HT70

    MDR report key: 3248789 · Received July 22, 2013

    Report

    Report Number
    3248789
    Event Type
    Death
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 22, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WALL OXYGEN OUTLET HAD A LOT OF PLAY BETWEEN THE WALL OUTLET AND THE FLOW METER. WHEN THE FLOW METER MOVED WITH TUBING BEING MOVED THE OXYGEN SUPPLY WAS CUTOFF. THIS WAS UNKNOWN TO THE STAFF BECAUSE THE VENTILATOR ALARM DID NOT GO OFF BECAUSE IT WAS TURNED OFF. THE VENTILATOR ALARM HAD THE CAPACITY TO BE TURNED OFF AND IT SHOULD NOT HAVE HAD THIS CAPABILITY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NUCLEAR SCANNING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340617 HT70 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death YES, WALL OXYGEN OUTLET VALVE NOT WORKING PROPERLY