BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIREG II

    MDR report key: 19227583 · Received May 2, 2024

    Report

    Report Number
    3003207908-2023-00001
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    September 11, 2023
    Report Date
    April 30, 2024
    Manufacturer
    GCE, S.R.O.,
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS AN INFORMATION THAT THE O-RING USED ON PRESSURE REGULATOR´S INLET CONNECTION IN TIME OF THE EVENT WAS FROM NBR WHICH IS MATERIAL NOT RECOMMENDED TO BE USED IN OXYGEN SERVICE.THE MEDIREG CONNECTION IS DAMAGED WITH A LEAK ACROSS THE O-RING DUE TO POOR MAINTENANCE THAT CONTRIBUTED TO IGNITION. THE MOST PROBABLE ROOT CAUSE OF IGNITION WAS INCORRECT USE - CONTRARY TO INFORMATION IN IFU; O-RING FROM NBR MATERIAL.

    Description of Event or Problem · 0

    RIGIN DESRIPTION OF THE INCIDENT: DATE: (B)(6) 2023 LOCATION: (B)(5). INCIDENT DESCRIPTION: "PATIENT COMPLAINED THAT HIS REGULATOR WAS "SMOKING". HE MENTIONED THAT FOLLOWING THE IGNITION HE EVEN REPLACED OR ADDED ANOTHER O RING THE INCIDENT WAS KNOWN TO US AT A LATER STAGE. PATIENT CONTINUED TO USE THE REGULATOR FOLLOWING "IGNITION INCIDENT". REGULATOR ALSO SHOWS MARKS OF DAMAGE DUE TO DROP OUTCOME: NO INJURIES. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811585 MEDIREG II MEDIREG II CAN GCE, S.R.O., 0724114 0009638611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other