BEUDAMED
    FDA Adverse Event Other Summary report: N

    MXR-2000

    MDR report key: 86290 · Received April 17, 1997

    Report

    Report Number
    2518157-1997-00005
    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
    ID, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    AN ANALGESIA GAS MACHINE (FLOWMETER) WAS RETURNED FOR REPAIR AND WAS RECEIVED ON 3/13/97 WITH A NOTE SAYING "SAFETY BLOWN - WILL FLOW N2O WITH O2 SHUT DOWN TO ZERO". THIS INSTRUMENT IS DESIGNED TO DELIVER MIXED O2 AND N2O TO A DENTAL PATIENT. WHEN O2 FLOW OR PRESSURE IS NOT PRESENT, INSTRUMENT HAS A FEATURE WHICH STOPS FLOW OF N2O. THIS FEATURE, THEREFORE, HAD MALFUNCTIONED. UPON EVALUATION CONDITION OF NITROUS OXIDE (N2O) FLOW WITHOUT OXYHEN (O2) COULD NOT BE REPRODUCED. CO FOLLOW-UP REPORT OF DENTIST CONTACT STATES "OBSERVATION WAS MADE DURING A FAILSAFE CHECK." 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 HAS FILED AN EXEMPTION WITH FDA ON 11/6/96.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other