BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATEX-OHMEDA HMEF 1000, DISPOSABLE

    MDR report key: 529389 · Received February 25, 2004

    Report

    Report Number
    9610105-2004-00006
    Event Type
    Other
    Date Received
    February 25, 2004
    Date of Event
    January 9, 2004
    Report Date
    January 11, 2004
    Manufacturer
    DATEX-OHMEDA DIVISION, INSTRUMENTARIUM CORP.
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RESTRICTION OF GAS AGENTS TO THE PT OCCURRED WHEN THE PT WAS ON THE TABLE THE CONSULTANT WENT THROUGH PROCESS OF ELIMINATION TO FIND THE PROBLEM AND ONE OF THE POSSIBILITIES COULD BE A BLOCKED FILTER. A NEW FILTER WAS PUT IN PLACE AND NORMAL FLOW WAS RETURNED, HOWEVER THEY ALSO CALLED IN THE DRAGER ENGINEER TO EXAMINE THE MACHINE AND IT IS MORE LIKELY THAT THIS OR HUMAN ERROR WAS TO BLAME. TO ENSURE THAT ALL POSSIBILITIES WERE ELIMINATED CO HAS BEEN ASKED TO EXAMINE THE FILTER AND REPORT BACK SO IT CAN BE HELD ON THE INTERNAL FILE THAT WILL GO WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA HMEF 1000, DISPOSABLE FILTER, BACTERIAL, BREATHING-CIRCUIT CAH DATEX-OHMEDA DIVISION, INSTRUMENTARIUM CORP. NA 30327

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other