BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTEC

    MDR report key: 207262 · Received January 22, 1999

    Report

    Report Number
    MW1015484
    Event Type
    Malfunction
    Date Received
    January 22, 1999
    Date of Event
    January 17, 1999
    Report Date
    January 22, 1999
    Manufacturer
    FLOTEC, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER WISHES TO REPORT A POTENTIAL HAZARD FOR THE USE OF A PORTABLE OXYGEN REGULATOR. RPTR STATES THAT THE THREADED INSERT THAT IS USED TO REGULATE PRESSURE IS MADE OF "CHEAP ALUMINUM". ON MANY OCCASION, IT HAS "SHOT OUT" OF THE REGULATOR. RPTR IS CONCERNED, BECAUSE THE PROJECTILE CAN CAUSE INJURY, AND PT WHO NEED OXYGEN ARE AT RISK FOR GOING WITHOUT DUE TO FAULTY REGULATORS. RPTR STATES THAT ON AVERAGE, 3 OF 5 REGULATORS FAIL. FOR THIS EVENT, THE INSERT POPPED OUT, BUT NO ONE WAS INJURED. THE PT WAS BEING TRANSPORTED INTO THE AMBULANCE DURING THE EVENT, SO "BOARD" OXYGEN WAS PLACED ON PT. RPTR STATES THAT HE HAS CONTACTED THE SERVICING AGENT, WHO REPAIRS THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTEC PORTABLE OXYGEN REGULATOR CAN FLOTEC, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN