BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCMS -QP2020 CL,GCMS-TQ8050 CL

    MDR report key: 17433491 · Received August 1, 2023

    Report

    Report Number
    8030233-2023-00004
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    June 6, 2023
    Report Date
    August 1, 2023
    Manufacturer
    SHIMADZU COPORATION
    Product Code
    DOP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SHIMADZU HAVE NEITHER REGISTERED NOR SOLD THE GC-FID DESCRIBED IN REPORT AS A MEDICAL DEVICE. WE MANUFACTURE GCMS-QP 2020 CL AND GCMS-TQ8050 CL AS MEDICAL DEVICES WITH THE FUNCTION OF MASS SPECTROMETRY AND HAS REGISTERED THEM WITH FDA, BUT THEY DO NOT HAVE THE FUNCTION OF FLAME IONIZATION DETECTOR GAS SAVER DESCRIBED IN THE REPORT. WE ALSO CONFIRMED THAT THERE ARE NO SALES RESULTS IN THE UNITED STATES.BASED ON THE ABOVE, IT WAS CONCLUDED THAT THE EVENT WOULD NEVER HAPPEN IN GCMS-QP 2020 CL AND GCMS-TQ8050 CL REGISTERED AS MEDICAL DEVICES IN THE UNITED STATES.SINCE THE EVENT WAS NOT CAUSED BY A MEDICAL DEVICE, THE PATIENT IS NOT HARMED.CORRECTIVE ACTIONS AND PREVENTIVE MEASURES ARE DEEMED UNNECESSARY BECAUSE THEY NEVER HAPPEN.

    Description of Event or Problem · 0

    WE WERE INFORMED BY MDR REPORT#: MW5118712 THAT "SHIMADZU GC-FID--GAS CHROMATOGRAPHY FLAME IONIZATION DETECTOR GAS SAVER DOES NOT WORK WITH HYDROGEN AS BOTH THE CARRIER GAS AND IGNITION SOURCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343710 GCMS -QP2020 CL,GCMS-TQ8050 CL GAS CHROMATOGRAPH-MASS SPECTROMETRY DOP SHIMADZU COPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown