BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS

    MDR report key: 743964 · Received June 23, 2005

    Report

    Report Number
    2517967-2005-00080
    Event Type
    Malfunction
    Date Received
    June 23, 2005
    Date of Event
    May 11, 2005
    Report Date
    May 11, 2005
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    H.3 A BIOMED AT THE FACILITY PERFORMED AN EVALUATION OF THE ANESTHESIA MACHINE AND AS REPORTED, THE INSPIRATORY VALVE DISC WAS FOUND TO HAVE BROKEN. THE CERAMIC VALVE DISC WAS REPLACED AND THE MACHINE FUNCTIONED NORMALLY.

    Description of Event or Problem · 1

    DURING A CASE, THE USER REPORTED THAT THE TIDAL VOLUME READINGS BECAME ERRATIC AND ALARMS WERE POSTED BY THE MACHINE. THE ANESTHESIA MACHINE WAS REPLACED TO COMPLETE THE CASE. NO PT INJURY. AFTER THE CASE, VISUAL EXAMINATION OF THE MACHINE FOUND THAT THE INSPIRATORY VALVE DISC HAD BROKEN. DATE OF OCCURRENCE WAS EITHER 05/11/05 OR 05/12/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FABIUS ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. GS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA