BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 17361471 · Received July 20, 2023

    Report

    Report Number
    2518435-2023-00019
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 26, 2023
    Report Date
    August 18, 2023
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657973033
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INITIAL DECISION TO REPORT WAS INCORRECT RESULTING IN THE INITIAL REPORT BEING SUBMITTED IN ERROR. THIS REPORT DOES NOT MEET CRITERIA FOR REPORTING AS A DEVICE MALFUNCTION OR A SERIOUS INJURY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). NO FURTHER REPORT WILL BE SUBMITTED UNDER THIS MFG:2518435-2023-00019.

    Description of Event or Problem · 0

    A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, OPHTHALMIC BLACK REGULATOR KNOB HAD SLIPPERY MALFUNCTION AND THE GAS COULD NOT COME OUT WHEN TURNED ON THE KNOB. THE SURGERY WAS COMPLETED AFTER A NEW REGULATOR WAS USED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910833 ISPAN GAS TANK REGULATOR INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 229210 00380657973033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown