BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATEX-OHMEDA COMPACT ABSORBER

    MDR report key: 493992 · Received October 30, 2003

    Report

    Report Number
    9610105-2003-00012
    Event Type
    Other
    Date Received
    October 30, 2003
    Date of Event
    October 8, 2003
    Report Date
    October 28, 2003
    Manufacturer
    INSTRUMENTARIUM CORP./DATEX-OHMEDA DIVISION
    Product Code
    BSF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT IT WAS ALMOST IMPOSSIBLE TO VENTILATE THE PATIENT; THE PATIENT WAS GIVEN LOTS OF DRUGS BECAUSE THE DOCTOR SUSPECTED THE PATIENT TO HAVE SOME KIND OF RESPIRATION SPASM. AFTER INVESTIGATION THE HOSPITAL FOUND THE PROBLEM. THE PROBLEM WAS CAUSED BY SEALING-LIP OF THE SODALIME CANISTER. THE NURSE THAT HAS INSTALLED THE NEW CASSETTE IN THE MORNING HAD REMOVED THE WHITE SEALING-LIP; THAT SEALING-LIP DID NOT COME OFF COMPLETELY, ONE DOME REMAINED AROUND ONE OF THE MALE CONES. THE ADU DID PASS ALL THE INITIAL LEAK TESTS AND DID NOT NOTICE THAT ONE LEG OF THE CANISTER WAS STILL SEALED.

    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