BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 20571130 · Received October 30, 2024

    Report

    Report Number
    2020676-2024-00018
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 30, 2024
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    BZR
    UDI-DI
    00899660002796
    PMA / PMN Number
    K992503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED TO OUR EU DISTRIBUTOR THAT THE SECHRIST AIR/OXYGEN GAS MIXER HAD AN ALARM ISSUE. NO PATIENT INVOLVEMENT OR INJURY REPORTED. NEITHER CUSTOMER OR DISTRIBUTOR REPORTED TO FDA ACCORDING TO THE INFORMATION WE HAVE AT THIS TIME. DEVICE IN QUESTION WILL NOT BE EVALUATED BY SECHRIST AS DISTRIBUTOR WILL EVALUATE AND SERVICE. AT THIS TIME, THE REPORT IS BASED ON THE INFORMATION WE HAVE. WE HAVE REQUESTED MORE INFORMATION FROM THE CUSTOMER IN REGARDS TO THE INCIDENT, AND OUR DISTRIBUTOR IN REGARDS TO SERVICE RECORDS AND EVALUATION/REPAIR OF THE DEVICE IN QUESTION. MANUFACTURER REFERENCE FILE NO. (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED, "GAS SHORTAGE ALARM NOT WORKING. AS THE ALARM IS NOT WORKING, DOES THIS MEAN THERE IS NO AUDIBLE SIGNAL? IF SO, COULD IT BE THAT THE FOLLOWING OCCURRED AND THEREFORE THE ALARM WAS MISSING: WARNING: THE GAS MIXER AUDIBLE ALARM MAY NOT FUNCTION WHEN BOTH AIR AND OXYGEN INLET PRESSURES ARE LESS THAN THE MINIMUM SPECIFIED INLET PRESSURE OF 30 PSIG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896607 SECHRIST INDUSTRIES INC. OXYGEN/AIR BREATHING GAS MIXER, HOSPITAL BZR SECHRIST INDUSTRIES INC. YES 00899660002796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown