BEUDAMED
    FDA Adverse Event Other Summary report: N

    S/5 ANAESTHESIA MONITOR

    MDR report key: 574443 · Received February 7, 2005

    Report

    Report Number
    9610105-2005-00002
    Event Type
    Other
    Date Received
    February 7, 2005
    Date of Event
    December 12, 2004
    Report Date
    February 7, 2005
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    CCK
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ACX MEASURING PCB UNIT ALLEGEDLY CAUGHT FIRE AND FILLED THE OPERATING ROOM WITH SMOKE. THE PATIENT AND MEDICAL FACILITY STAFF WERE IN ROOM BUT THE OPERATOR HAD NOT COMMENCED. PATIENT AND STAFF WERE SUCCESSFULLY EVACUATED. THE UNIT WAS DISCONNECTED FROM THE ELECTRICAL SUPPLY. NO ADVERSE EFFECTS TO PATIENT OR STAFF WERE REPORTED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/5 ANAESTHESIA MONITOR AIRWAY MODULE G-AIO(V) CCK GE HEALTHCARE FINLAND OY EXC880270 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN