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

Model Number	114093-000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• 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: 24215373
• Report Number: 3010326005-2026-00001
• Device Sequence Number: 12783791
• Product Code: FQO
• UDI-Device Identifier: 00857534006356
• UDI-Public: (01)00857534006356(11)20160218
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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: 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: 01/10/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2016
• 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