MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. ORT300 TABLE; OPERATING ROOM TABLE

Model Number	ORT300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The imris customer service engineer investigated the issue on-site and observed a small hydraulic fluid leak from a pressurized input hose associated with the back lift cylinder.The cse measured the hydraulic fluid level in the operating room table and confirmed it was within specification.The table was functionally tested and no functional issues were present or previously reported by the customer.Replacement of the hydraulic hose is in process; a follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
A biomedical technician at the customer site reported observing hydraulic fluid at the base of the ort300 operating room table.There was no patient or procedural involvement at the time of the observation.
Additional Manufacturer Narrative
The imris service engineer replaced flow control valves and additional hydraulic hoses and fittings in the hydraulic system adjacent to the flow control valves to address the reported fluid leak.Hydraulic fluid levels and system pressure were measured during the service visits and confirmed to be within specification.No table functional impact was reported by the customer or observed by the service engineer throughout multiple site visits, on-site testing, and followup preventive maintenance visits.This report also encompasses udi related data quality updates to match brand name and udi with gudid data.

• Brand Name: ORT300 TABLE
• Common Device Name: OPERATING ROOM TABLE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: paul campbell ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; 7632036344
• MDR Report Key: 18088480
• Report Number: 3010326005-2023-00012
• Device Sequence Number: 5884385
• Product Code: KXJ
• UDI-Device Identifier: 00857534006356
• UDI-Public: (01)00857534006356(11)20160218
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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
• Operator of Device: Other
• Device Model Number: ORT300
• Device Catalogue 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: 10/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 02/21/2025
• 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