BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASS SPECTROMETER, CLINICAL USE

    MDR report key: 19605680 · Received June 25, 2024

    Report

    Report Number
    3009715051-2024-00002
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    June 13, 2024
    Report Date
    June 25, 2024
    Manufacturer
    AB SCIEX PTE. LTD.
    Product Code
    DOP
    Removal / Correction Number
    Z-0037-2024,Z-0038-2024,
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. A CORRECTION FOR SIMILAR MEDICAL DEVICES HAS BEEN IN PROCESS IN THE US AS REFERENCED IN SECTION H9 (Z-0037-2024, Z-0038-2024, Z-0039-2024, Z-0040-2024).

    Description of Event or Problem · 0

    A SMALL FIRE OCCURRED AT THE CUSTOMER LAB. THE CUSTOMER SMELLED SOMETHING BURNING AROUND THE SCIEX MASS SPECTROMETERS. THE ELECTRODE POPPED OUT (POSSIBLY FROM THE OVERHEATED SOURCE) INTO A VIAL RACK AND THAT IS WHAT CAUGHT FIRE. THE MELTED BLACK PART IS THE [ELECTRODE ADJUSTMENT NUT] OF THE PROBE [ASSEMBLY] THAT MELTED. [THE CUSTOMER] HAD TO USE THE FIRE EXTINGUISHER BUT WAS ABLE TO MOVE THE VIAL RACK TO THE SINK TO CONTAIN THE POWDER AND CLEANUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807987 MASS SPECTROMETER, CLINICAL USE DOP AB SCIEX PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other