BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS

    MDR report key: 587859 · Received March 30, 2005

    Report

    Report Number
    2517967-2005-00048
    Event Type
    Malfunction
    Date Received
    March 30, 2005
    Date of Event
    March 16, 2005
    Report Date
    March 16, 2005
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CASE, THE USER REPORTED THAT THE CO2 LEVELS WERE OBSERVED TO BE RISING. INVESTIGATION FOUND THAT A CERAMIC DISC HAD CRACKED IN THE INSPIRATION FOUND THAT A CERAMIC DISC HAD CRACKED IN THE INSPIRATORY VALVE. THE USER MANUALLY VENTILATED THE PATIENT WITH AN ALTERNATE DEVICE WHILE THE DISC WAS REPLACED. THE USER THEN COMPLETED THE CASE USING THE ANESTHESIA MACHINE. NO PATIENT INJURY.

    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