BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR GI

    MDR report key: 24866892 · Received April 13, 2026

    Report

    Report Number
    3017448360-2026-00002
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 13, 2026
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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. ON DECEMBER 18, 2025 LABORIE HAD A MEETING WITH THE FDA WHERE IN FDA REQUESTED COMPLAINTS FOR NEGATIVE PRESSURE BE RE-EVALUATED AND SUBMITTED AS AN MDR.

    Description of Event or Problem · 0

    ISSUE AS REPORTED: THE INFUSION PUMP SUDDENLY POPPED UP WITH A PROMPT INDICATING HIGH PRESSURE. AFTER CLICKING RESTART, THE INFUSION PRESSURE STABILIZED AT 1070MBAR AND DID NOT DROP TO THE SET 1000MBAR. WE NEED TO SEND IT TO THE FACTORY FOR INSPECTION AND REPAIR. I SEE ON A SCREEN THAT IT IS SET AT 1000MBAR, BUT THE PRESSURE IS 452MBAR THIS MEANS THE PRESSURE IS NOT REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104168 SOLAR GI SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX LABORIE MEDICAL TECHNOLOGIES CORP. SOLAR GI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other