MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT300 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	07/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspected source of the fluid leak is a valve component within the hydraulic manifold.No hydraulic pressure loss or impact on table function has been observed.A followup report will be submitted once the investigation is complete.
Event or Problem Description
During routine preventive maintenance, an imris customer service engineer observed several small drops of hydraulic fluid on outside of the hydraulic lines of the ort300 operating room table.No issues were reported or observed with respect to hydraulics controlled table functions.There was no patient involvement.
Additional Manufacturer Narrative
An imris customer service engineer made multiple site visits to address the preventive maintenance finding of a small hydraulic fluid leak from the operating room table.The source of the leak was not definitively determined, at a followup visit no fluid outside the hydraulic system was observed.Multiple suspected hydraulic system components were replaced as a preventive measure, including a flow control valve, a hose, and multiple fittings and unions.Hydraulic system pressure and fluid levels were measured to be within specification, and weighted drift testing was performed with passing results.No impact to table function was reported or observed.

• Brand Name: IMRIS ORT300 OPERATING ROOM TABLE
• Common Device Name: OPERATING ROOM TABLE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer (Section G): IMRIS - DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer Contact: paul campbell ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 15316924
• Report Number: 3010326005-2022-00014
• Device Sequence Number: 17434585
• Product Code: KXJ
• UDI-Device Identifier: 00857534006356
• UDI-Public: 00857534006356
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2022

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: 07/30/2022
• Supplement Date Received by Manufacturer: 07/30/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown