MAUDE Adverse Event Report: IMRIS IMAGING, INC. ORT300 TABLE; Table, operating-room, ac-powered

Model Number	114093-000
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Valve fittings were tightened to prevent further leaking and imris customer service engineer ordered the necessary parts to replace all leaking valves along with a new reservoir tank.The end user was notified of the finding and the ort300 remains functional.
Event or Problem Description
The customer notified imris customer service engineer via email, stating they had observed oil coming from the ort300 operating room table.The imris cse inspected the table and identified small amounts of hydraulic fluid leaking from the unpressurized fluid reservoir and from multiple valves within the pressurized hydraulic control system.No table functional issues were identified or reported.There was no patient involvement.

• Brand Name: ORT300 TABLE
• Common Device Name: Table, operating-room, ac-powered
• Manufacturer (Section D): IMRIS IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer (Section G): IMRIS IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: stacy kramer ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; 7632036338
• MDR Report Key: 23597673
• Report Number: 3010326005-2025-00005
• Device Sequence Number: 21166332
• Product Code: FQO
• UDI-Device Identifier: 00857534006356
• UDI-Public: (01)00857534006356(11)20170607
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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: 114093-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown