BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR (125GM)

    MDR report key: 14101690 · Received April 13, 2022

    Report

    Report Number
    1610287-2022-00021
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 21, 2022
    Report Date
    September 7, 2022
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    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

    NO SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF THE BATCH PRODUCTION RECORD FOR THE GIVEN LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A REVIEW OF THE COMPLAINT RECORDS SHOWED ONE OTHER COMPLAINT AGAINST THE GIVEN LOT. THAT COMPLAINT WAS FOR ISSUES WITH THE CONTROL VALVE. A REVIEW OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT DURING A VITRECTOMY SURGERY AN OPHTHALMIC REGULATOR FAILED TO DISPENSE GAS. SURGERY WAS COMPLETED AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787600 ISPAN GAS TANK REGULATOR (125GM) INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 104323

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown