BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTEC

    MDR report key: 360428 · Received November 13, 2001

    Report

    Report Number
    MW1023382
    Event Type
    Malfunction
    Date Received
    November 13, 2001
    Date of Event
    October 27, 2001
    Report Date
    November 13, 2001
    Manufacturer
    FLOTEC, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FLOTEC OXYGEN REGULATORS COME WITH A YOKE WASHER SEAL WHICH, AFTER A COUPLE OF USES, TENDS TO COME OFF THE REGULATOR. A RESPIRATORY THERAPIST WAS UNABLE TO LOCATE A FLOTEC SEAL, AND USED THE PLASTIC SEAL PROVIDED WITH THE O2 TANK PLUS ANOTHER PIECE OF FLEXIBLE MATERIAL HE OBTAINED FROM A HEAD DEVICE. HE THEN TURNED ON THE OXYGEN TANK, JIGGLED THE REGULATOR CAUSING A SPARK WHICH IGNITED THE SEAL MATERIALS AND RESULTED IN A FIRE. THERE WAS NO PT INVOLVED AND THE RESPIRATORY THERAPIST WAS NOT INJURED. THE TWO PROBLEMS ARE 1- THAT THE YOKE WASHER SEALS REQUIRE FREQUENT REPLACEMENT SINCE THEY DO NOT STAY ON THE REGULATORS, AND 2- THE MFR HAS INDICATED THAT ONLY FLOTEC YOKE WASHER SEALS SHOULD BE USED ON ITS REGULATORS, BUT THAT IS NOT CLEARLY INDICATED IN THE PRODUCT INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51220 FLOTEC YOKE WASHER SEAL CAN FLOTEC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other FLOTEC OXYGEN REGULATOR, P/N RR8004-3104M1.