BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISELECT II

    MDR report key: 19227490 · Received May 2, 2024

    Report

    Report Number
    3003207908-2021-00001
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    September 2, 2021
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST POSSIBLE CAUSE OF IGNITION: INSUFFICIENT TIGHTENING OF THE INLET NUT ON THE CYLINDER VALVE.

    Description of Event or Problem · 0

    ORIGINAL DESCRIPTION OF EVENT IN (B)(6) HOSPITAL (B)(6) GERMANY: A EMPLOYEE CONNECTED AN OXYGEN PRESSURE REDUCTION VALVE TO A 3L CYLINDER. THE REDUCTION VALVE GOT HOT DURING OPENING THE CYLINDER VALVE. THAN THE EMPLOYEE CLOSED THE VALVE AND BURNED HIS HAND. THE EMPLOYEE AFFIRMED THAT HE HAD NOT USED ANY DISINFECTANTS OR HAND CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919599 MEDISELECT II MEDISELECT II CAN GCE, S.R.O., 0720124 9024359

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other