MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS T2X OR TABLE V2 (ORT100); OPERATING ROOM TABLE

Model Number	ORT100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hydraulic fluid leak was traced to the o-ring gasket between the hydraulic fluid reservoir and the hydraulic pump.The gasket had degraded over time and required replacement.
Event or Problem Description
On (b)(6) 2022, during preventive maintenance an imris customer service eningineer observed a small leak of hydraulic fluid in the wall mounted control panel of the t2x operating room table.There was no patient involvement and the table passed functional testing during the preventive maintenance service.

• Brand Name: IMRIS T2X OR TABLE V2 (ORT100)
• 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: 14805692
• Report Number: 3010326005-2022-00010
• Device Sequence Number: 4653024
• Product Code: KXJ
• UDI-Device Identifier: 00857534006332
• UDI-Public: (01)00857534006332
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 05/25/2022

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: ORT100
• Device Catalogue Number: 110470-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2012
• 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
• Patient Sex: Unknown