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

Model Number	ORT300
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	06/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The imris customer service engineer addressed the issue on-site.A fitting securing a pressurized hydraulic line connection was identified as the source of the leak and was adjusted and tightened.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.The cse inspected the table on a follow-up site visit and confirmed the absence of any fluid leaks.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
During routine preventive maintenance, an imris customer service engineer observed drops of hydraulic fluid outside of the hydraulic lines of the ort300 operating room table.The source of the leak was traced to a fitting on a pressurized hydraulic line.No table functional issues were identified during subsequent testing.There was no patient involvement.
Additional Manufacturer Narrative
The imris service engineer replaced fittings and hoses within the hydraulic system that controls trendelenburg position articulation.Hydraulic fluid levels and system pressure were measured during multiple service visits and confirmed to be within specification.No table functional impact was reported by the customer or observed by the service engineer during the site visits.The service engineer performed drift testing twice during the repair period, which passed.Followup preventive maintenance has confirmed absence of further fluid leak.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: 17375352
• Report Number: 3010326005-2023-00008
• Device Sequence Number: 3715545
• Product Code: KXJ
• UDI-Device Identifier: 00857534006356
• UDI-Public: (01)00857534006356(11)20160218(21)10004372
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 02/24/2025
• 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