BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISELECT II

    MDR report key: 19227562 · Received May 2, 2024

    Report

    Report Number
    3003207908-2022-00001
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    February 6, 2022
    Report Date
    April 30, 2024
    Manufacturer
    GCE, S.R.O.,
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    POTENTIAL CAUSE OF IGNITION ( OR MORE PROBABLY IGNITION MECHANISM CAUSED BY COMBINATION OF SOME FACTORS): INSUFFICIENT TIGHTENING OF THE INLET NUT ON THE SOV VALVE. THERE COULD BE IMPURITIES ON THE INLET CONNECTION O-RING. - THE OUTLET CONNECTION OF SHUT-OFF VALVE COULD BE CONTAMINATED / SCRATCHED. QUICK OPENED CYLINDER VALVE.

    Description of Event or Problem · 0

    ORIGINAL DESCRIPTION OF EVENT IN (B)(6) HOSPITAL : "BEFORE THE START OF TRANSPORT, THE PRESSURE REGULATOR WAS CHECKED FOR FUNCTION AND THE COMPRESSED GAS TANK FOR FILL LEVEL, NO ABNORMALITIES WHATSOEVER. AT ARRIVAL IN THE OPERATING THEATER, TRANSFER OF THE UNIT TO THE ANESTHESIA TEAM, NO FURTHER IRREGULARITIES. WHEN THE CYLINDER WAS OPENED AGAIN, A LOUD OUTFLOW NOISE WAS HEARD, ALMOST AT THE SAME TIME SPARKS COULD BE SEEN. VALVE WAS CLOSED IMMEDIATELY. SIGNIFICANT BURN MARKS ON THE PRESSURE REGULATOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841609 MEDISELECT II MEDISELECT II CAN GCE, S.R.O., 0720123 9341998

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other