BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATEX-OHMEDA COMPACT ABSORBER

    MDR report key: 594065 · Received June 9, 2004

    Report

    Report Number
    9610105-2004-00008
    Event Type
    Other
    Date Received
    June 9, 2004
    Date of Event
    April 7, 2004
    Report Date
    May 12, 2004
    Manufacturer
    INSTRUMENTARIUM CORP./DATEX-OHMEDA DIVISION
    Product Code
    BSF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE OR STAFF RECENTLY EXPERIENCED A CASE IN WHICH THE COVER RIPPED, LEAVING PART OF THE COVER OF THE ABSORBER. DESPITE THE PRESENCE OF THE REMAINING BRIGHT ORANGE COVER, THE ABSORBER WAS ABLE TO CONNECT TO THE ANESTHESIA MACHINE AND PASSED THE SUBSEQUENT LEAK TEST.

    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 488014

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other