BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASS SPECTROMETER

    MDR report key: 17515044 · Received August 11, 2023

    Report

    Report Number
    3009715051-2023-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    June 16, 2023
    Manufacturer
    AB SCIEX PTE. LTD.
    Product Code
    DOP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE INCIDENT IS NOT A MEDICAL DEVICE. HOWEVER, IT CAN BE CONSIDERED TO BE SIMILAR TO SCIEX'S MARKETED MASS SPECTROMETERS AS THEY SHARE DESIGN CHARACTERISTICS AND COMPONENTS. AS A RESULT, THE MALFUNCTION MAY OCCUR WITH SCIEX'S MEDICAL DEVICES WITH A REMOTE PROBABILITY OF A SERIOUS INJURY.

    Description of Event or Problem · 0

    FLAME WAS OBSERVED ON TOP OF THE IONO SOURCE AND PROBE ASSEMBLY. THE CUSTOMER TURNED OFF THE INSTRUMENT. DUE TO THE DEFECT OF THE SOURCE, NO SAMPLE CAN BE INTRODUCED TO THE INSTRUMENT FOR ANALYSIS. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181817 MASS SPECTROMETER DOP AB SCIEX PTE. LTD. 5060744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other