BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E500 VENTILATOR

    MDR report key: 1025533 · Received April 1, 2008

    Report

    Report Number
    2023050-2008-00022
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 7, 2008
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ERROR MESSAGE "GDM DISCONNECTED" SHOWN IN THE MONITOR DURING IN USE ON A PT IN 2008. THEN THE HOSPITAL STAFF NOTICED THAT IT SMELLED SOMETHING BURNING, SO THE STAFF DISCONNECTED THE UNIT FROM THE PT AND IT WAS TURNED OFF. THE UNIT WAS TURNED BACK ON BY THE IMPORTER ON THE FOLLOWING DAY. RIGHT AFTER THE UNIT WAS TURNED ON; A LOT OF SMOKE CAME OUT FROM THE UNIT AND SPREAD IN THE ICU ROOM. PLEASE NOTE THAT THERE WAS NO SERIOUS INJURY OR DEATH IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E500 VENTILATOR VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK