BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION MIXER

    MDR report key: 158271 · Received March 23, 1998

    Report

    Report Number
    MW1013354
    Event Type
    Malfunction
    Date Received
    March 23, 1998
    Date of Event
    March 16, 1998
    Report Date
    March 23, 1998
    Manufacturer
    MATRIX MEDICA, INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE RPTR IS CALLING TO REPORT ON WHAT HE VIEWS AS A POTENTIALLY DANGEROUS SITUATION. THE CENTURION MIXER IS USED DURING DENTAL PROCEDURES TO ADMINISTER NITROUS OXIDE AND OXYGEN. ACCORDING TO THE RPTR, ANY PROCEDURE INVOLVING THE USE OF NITROUS OXIDE SHOULD BE FOLLOWED BY SEVERAL MINS OF 100% OXYGEN AFTER DISCONTINUING THE NITROUS OXIDE. ACCORDING TO THE RPTR, THE DEVICE IS COMPLETELY DEPENDENT UPON AC POWER BOTH FOR ITS OPERATION AND DISPLAYS. IF AC POWER IS LOST, THE MACHINE SHUTS DOWN. WHEN THE MACHINE SHUTS DOWN, THE PROVIDER LOSES THE ABILITY TO ADMINISTER OXYGEN. ALTHOUGH THE RPTR IS AWARE THAT AN EMERGENCY SUPPLY OF OXYGEN SHOULD ALWAYS BE AVAILABLE, HE FEELS THE DELAY IN SETTING UP THE EMERGENCY SUPPLY OF OXYGEN POSES AN UNACCEPTABLE RISK TO THE PT. THE RPTR FEELS A WARNING LABEL WOULD NOT ADEQUATELY ADDRESS THIS ISSUE, BUT HE DOES BELIEVE A BACK UP DC POWER SUPPLY WOULD RESOLVE THE ISSUE AND INCREASE PT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION MIXER NITROUS OXIDE MACHINE BSZ MATRIX MEDICA, INC. CENTURION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA