BEUDAMED
    FDA Adverse Event Other Summary report: N

    NORTH AMERICAN DRAGER

    MDR report key: 836798 · Received April 5, 2007

    Report

    Report Number
    MW1042501
    Event Type
    Other
    Date Received
    April 5, 2007
    Date of Event
    April 4, 2007
    Report Date
    April 5, 2007
    Manufacturer
    *
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DRAGER APOLLO ANESTHESIA MACHINE, HAD SOFTWARE UPDATE BY MFR DAY PRIOR TO EVENT. DEVICE HAS BEEN IN USE APPROX 4 MOS. ON DAY OF EVENT DEVICE CHECKED OUT USING MFR RECOMMENDED PROTOCOL USING INTERNAL SELF DIAGNOSTIC PROTOCOL WITH MANUAL CHECKS PER RELEVANT FDA GUIDANCE. DURING FIRST GENERAL ANESTHETIC OF DAY FIO2% BEGAN TO READ ERRATICALLY -16-80% WITH SET FIO2 OF APPROX 30%. PT SWITCHED TO BACK UP TANK ON MACHINE, THEN SEPARATE O2 SOURCE WITH 100% FIO2. PT FIO2 MONITORED USING MINIOX 3000 PORTABLE FIO2 MONITOR TO CONFIRM PURITY OF DELIVERED GAS. SELF DIAGNOSTIC BY MACHINE AGAIN REVEALED NO FAULT. TWO OF OUR OTHER APOLLOS ALSO HAD THE SOFTWARE UPDATE, ONE OF WHICH HAD THE SAME FAULT ON TESTING. THE ONE THAT DID NOT SUFFER THE SAME FAULT WAS RECENTLY DELIVERED -WITHIN A WEEK- AND IS PRESUMABLY NEWER. PT UNDERWENT SUCCESSFUL SURGERY, WITHOUT INCIDENT. DRAGER AFFILIATE HAS BEEN NOTIFIED -HOSPITAL IN ANOTHER COUNTRY- AND HAS BEEN VERY HELPFUL AND WILL BE ON SITE 04/06/07 TO EVALUATE OUR MACHINES (4). MY CONCERN IS THAT MACHINES PASS SELF-DIAGNOSTIC AND RECOMMENDED CLINICAL PRE-USE ASSESSMENT AND THEN FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORTH AMERICAN DRAGER APOLLO ANESTHESIA MACHINE BSZ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other