BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR GI

    MDR report key: 23967719 · Received January 5, 2026

    Report

    Report Number
    3017448360-2025-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    September 11, 2025
    Report Date
    January 5, 2026
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    FFX
    UDI-DI
    08717775955047
    PMA / PMN Number
    K121014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT DETAILS A MALFUNCTION OF THE SOLAR GI DEVICE, A MALFUNCTION THAT WAS NOT OBSERVED DURING USE OF THE DEVICE ON A PATIENT.

    Description of Event or Problem · 0

    THE PUMP WAS FAULTY RESULTING IN NEGATIVE PRESSURE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28601 SOLAR GI SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX LABORIE MEDICAL TECHNOLOGIES CORP. BASE SOFTWARE MODULES, G3-8 N/A 08717775955047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other