BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATEX-OHMEDA COMPACT ABSORBER

    MDR report key: 484523 · Received September 19, 2003

    Report

    Report Number
    9610105-2003-00009
    Event Type
    Other
    Date Received
    September 19, 2003
    Date of Event
    September 9, 2003
    Report Date
    September 18, 2003
    Manufacturer
    INSTRUMENTARIUM CORP./DATEX-OHMEDA DIVISION
    Product Code
    BSF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT IN 2003 WAS PROVOKED DUE TO THE FACT THAT AN EMPLOYEE OF THE ANESTHESIA DEPT MOUNTED THE CANISTER ON THE BREATHING SYSTEM OF A DATEX-OHMEDA S/5 ADU INCL. THE LATCH. DURING THE TEST PROCEDURE OF THE ADU, THE MACHINE DID NOT DETECT A FAULT OR FAILURE AS THE MACHINE DIAGNOSED A LEAK FREE SYSTEM. THE MOUNTING OF A CASSETTE WITH THE LATCH STILL IN PLCE IS VERY DIFFICULT AND REQUIRES EXTRAORDINARY FORCE, BUT SEEMS TO BE POSSIBLE. DURING ANESTHESIA, PROBLEMS OCCURRED AS THE STAFF DETECTED VENTILATION PROBLEMS WHILE ATTEMPTING TO VENTILATE THE PT MANUALLY AFTER INTUBATIONS. THE RESISTANCE WAS HIGH (!). THE PT WAS EXTUBATED AND REINTUBATED. REEXAMINING THE SYSTEM THE STAFF DETECTED THAT THE COMPACT CASSETTE WAS MOUNTED WITH THE LATCH STILL IN PLACE. THE LATCH, OF COURSE, OCCLUDED THE PORT OF ENTRY FOR FRESH GAS. THE ANESTHESIA DEPT REPORTED THE INCIDENT TO THE "NEAR INCIDENT" HOSP OFFICIAL WHO SUBMITTED THE REPORT. THE PRODUCT INFO ENCLOSED IN EACH BOX OF TEN CANISTERS IS NOT STATING ANY PRECAUTIONS ON THE REMOVAL OF THE LATCH, ALTHOUGH IT IS VERY LOGICAL. IMMEDIATELY ANANDIC COMPOSED AN ADD'L WARNING DOCUMENT IN FRENCH AND GERMAN TO BE PACKED INSIDE THE ORIGINAL PACKAGING, INFORMING THE USERS TO REMOVE THE LATCH BEFORE MOUNTING THE CANISTER. THIS PRECAUTION ACTION HAS BEEN TAKEN IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA COMPACT ABSORBER DATEX-OHMEDA ABSORBER, SINGLE USE BSF INSTRUMENTARIUM CORP./DATEX-OHMEDA DIVISION 427002100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other