BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDISORB MULTI ABSORBER

    MDR report key: 554177 · Received April 19, 2004

    Report

    Report Number
    9610105-2004-00007
    Event Type
    Other
    Date Received
    April 19, 2004
    Date of Event
    March 31, 2004
    Report Date
    April 1, 2004
    Manufacturer
    INSTRUMENTARIUM CORP. DATEX-OHMEDA DIV
    Product Code
    BSF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT: CANNOT VENTILATE PT, NOR IN MANUAL NOR IN VENT. MODE. THE FIELD ENGINEER DISCOVERED THAT A NURSE HAD MOUNTED A NEW SODALIME CANISTER JUST BEFORE THE START OF A NEW PT AND THAT THE CANISTER STILL HAD THE GREEN COVER-LIP ON. CO TESTED SEVERAL CANISTERS AND IT IS INDEED EASY TO INSTALL A CANISTER WITH THE COVER LIP STILL ON. WHEN YOU DO SO AND CARRY OUT A NORMAL FUNCTIONAL TEST THE AVANCE WILL WARN YOU, BUT SOMEONE DURING AN OPERATION HAS TO REPLACE A CANISTER IT CAN EASILY HAPPEN AGAIN. EXTRA: THREEE WEEKS AGO THE SAME HOSP MANAGED TO PUT THAT CANISTER THE OTHER WAY AROUND (DRAIN RESERVOIR TO THE FRONT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISORB MULTI ABSORBER DATEX-OHMEDA MULTI ABSORBER, DISPOSABLE BSF INSTRUMENTARIUM CORP. DATEX-OHMEDA DIV 8003138 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other