BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD-1000

    MDR report key: 68499 · Received February 10, 1997

    Report

    Report Number
    2518157-1997-00002
    Event Type
    Malfunction
    Date Received
    February 10, 1997
    Report Date
    February 7, 1997
    Manufacturer
    PORTER INSTRUMENT CO., INC.
    Product Code
    LWM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    AN ANALGESIA GAS MACHINE (FLOWMETER) WAS RETURNED FOR REPAIR AND WAS RECEIVED ON 1/23/97 WITH A NOTE SAYING "ESTIMATE OF REPAIR-OVERHAUL". UPON EVAL IT WAS DETERMINED THAT THE FLOWMETER COULD FLOW NITROUS OXIDE (N2O) WITHOUT OXYGEN (O2). THIS INSTRUMENT IS DESIGNED TO DELIVER MIXED O2 AND N20 TO A DENTAL PT. WHEN O2 FLOW OR PRESSURE IS NOT PRESENT, THE INSTRUMENT HAS A FEATURE WHICH STOPS THE FLOW OF N2O. THIS FEATURE, THEREFORE, HAD MALFUNCTIONED. THE CO'S FOLLOW-UP REPORT OF THE DENTIST CONTACT STATES "NO PTS WERE EXPOSED TO 100% N2O". THEREFORE, AT NO TIME DID A PT RECEIVE 100% N2O FROM THIS DEVICE AS A RESULT OF THIS MALFUNCTION. CO HAS PREVIOUSLY SUBMITTED MDR'S WHEN THE FAILSAFE HAS MALFUNCTIONED. UNDER THE 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 THE FDA ON 11/6/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STD-1000 ANALGESIA GAS MACHINE LWM PORTER INSTRUMENT CO., INC. STD-1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other