MAUDE Adverse Event Report: Laborie Medical Technologies SolarGI HRIM SST Trolley System; Gastrointestinal motility monitoring system.

Model Number	SolarGI HRIM SST Trolley System
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction

• Brand Name: SolarGI HRIM SST Trolley System
• Common Device Name: Gastrointestinal motility monitoring system.
• Manufacturer (Section D): Laborie Medical Technologies; 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): Laborie Medical Technologies; 180 international drive; portsmouth NH 03801
• Manufacturer Contact: zulmar molina ; 180 international drive; portsmouth, NH 03801
• MDR Report Key: 50214327
• Report Number: 3017448360-2026-00003
• Device Sequence Number: 6110822
• Product Code: FFX
• UDI-Device Identifier: 08717775955108
• UDI-Public: 08717775955108
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SolarGI HRIM SST Trolley System
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown