BEUDAMED
    FDA Adverse Event Other Summary report: N

    MXR-2000

    MDR report key: 86274 · Received April 17, 1997

    Report

    Report Number
    2518157-1997-00006
    Event Type
    Other
    Date Received
    April 17, 1997
    Report Date
    April 16, 1997
    Manufacturer
    PORTER INSTRUMENT CO., INC.
    Product Code
    LWM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    AN ANALGESIA GAS MACHINE (FLOWMETER) WAS RETURNED FOR REPAIR AND WAS RECEIVED ON 3/24/97 WITH A NOTE SAYING "PLEASE REPAIR". THIS INSTRUMENT IS DESIGNED TO DELIVER MIXED O2 AND N2O TO A DENTAL PT. WHEN O2 FLOW OR PRESSURE IS NOT PRESENT, THE INSTRUMENT HAS A FEATURE WHICH STOPS FLOW IN N2O. THIS UNIT WAS INCLUDED IN 1986 MIXER MODIFICATION PROGRAM (MMP), A VOLUNTARY USER NOTIFICATION PROGRAM CONDUCTED BY COMPANY UNDER GUIDANCE OF FDA. UPON EVALUATION OF UNIT A CONDITION OF NITROUS OXIDE (N2O) FLOW WITHOUT OXYGEN (O2) FLOWING WAS PRODUCED. CO FOLLOW-UP REPORT OF DENTIST CONTACT STATES "THEY DID SEE N2O WITHOUT O2 FLOWING, THEN SHUT SYSTEM OFF AND RETURNED IT TO CO. THERE WERE NO ADVERSE EFFECTS TO PT AS INDICATED BY DOCTOR. CO HAS PREVIOUSLY SUBMITTED MDRS WHEN THE FAILSAFE HAS MALFUNCTIONED. UNDER CURRENT MDR REGULATIONS, CO HAS DETERMINED THAT THIS CATEGORY OF PRODUCT MALFUNCTION DOES NOT REQUIRE SUBMISSION OF AN MDR AND HAD FILED AN EXEMPTION WITH FDA ON 11/6/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MXR-2000 ANALGESIA GAS MACHINE LWM PORTER INSTRUMENT CO., INC. MXR-2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other