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	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once cause has been established.
Event or Problem Description
The operating room table was reported to be leaking hydraulic fluid.
Additional Manufacturer Narrative
The customer service engineer observed a small leak of hydraulic fluid in a ptfe hydraulic fluid return hose in the control panel for the ort100 table.The leak did not impact function of the table's hydraulic system.The hose was observed to have some damage consistent with it being impacted or smashed, and a prior preventive maintenance three months before this observation did not observe any damaged hoses or hydraulic fluid leaks.The ptfe hose was replaced and the table was tested to verify function.

• 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: 12381679
• Report Number: 3010326005-2021-00010
• Device Sequence Number: 13748203
• Product Code: KXJ
• UDI-Device Identifier: 00857534006332
• UDI-Public: (01)00857534006332
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2021

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: Health Professional
• Device Model Number: ORT100
• Device Catalogue Number: 110470-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/29/2021
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2010
• 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