FDA Adverse Event
Malfunction
Summary report: N
ORT300 TABLE
MDR report key: 24215373
·
Received January 29, 2026
Report
- Report Number
- 3010326005-2026-00001
- Event Type
- Malfunction
- Date Received
- January 29, 2026
- Date of Event
- January 10, 2026
- Report Date
- January 29, 2026
- Manufacturer
- IMRIS IMAGING, INC.
- Product Code
- FQO
- UDI-DI
- 00857534006356
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
FITTINGS WERE TIGHTENED TO PREVENT FURTHER LEAKING AND IMRIS CUSTOMER SERVICE ENGINEER WILL MONITOR TABLE FOR ADDITIONAL LEAKS. THE END USER WAS NOTIFIED OF THE FINDING AND THE ORT300 REMAINS FUNCTIONAL.
Description of Event or Problem · 0
THE IMRIS CUSTOMER SERVICE ENGINEER (CSE) NOTICED A SMALL HYDRAULIC LEAK COMING FROM THE HEIGHT VALVE ASSEMBLY DURING THE PREVENTATIVE MAINTENANCE (PM) OF THE ORT300 OPERATING ROOM TABLE. THERE WERE ALSO HYDRAULIC SPOTS NOTED AT THE TREND FLOW VALVE LOCATION. NO TABLE FUNCTIONAL ISSUES WERE IDENTIFIED OR REPORTED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279535 | ORT300 TABLE | Table, operating-room, ac-powered | FQO | IMRIS IMAGING, INC. | 114093-000 | 00857534006356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |