BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES T2100-ST2 TREADMILL

    MDR report key: 17886297 · Received October 5, 2023

    Report

    Report Number
    MW5146651
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Report Date
    October 4, 2023
    Manufacturer
    GE HEALTHCARE/ GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    IOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ¿GE IS DEPLOYING STRESS TEST TREADMILL WITH KNOWN DEFECT THAT CAUSES TREADMILL TO FALSE START (TREADMILL BELT MOVED ABOUT 1 INCH AND THEN HALTED). VENDOR HAS PROVIDED WORKAROUND AS THERE IS NO FIX RELEASED AT THIS TIME. FACILITIES ARE IN NEED OF FIRMWARE UPDATE ASAP AS WORKAROUND IS NOT A SUFFICIENT SOLUTION. GE T2100-ST2 IS THE AFFECTED MODEL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942671 SERIES T2100-ST2 TREADMILL TREADMILL, POWERED IOL GE HEALTHCARE/ GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown