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

Model Number	ORT100
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022 the head end of an ort t2x operating room table drifted approximately 6mm downward during a case.The drift was observed through a navigation system in use during the case.No patient or procedural impact was reported.
Additional Manufacturer Narrative
The manufacturer is seeking further information from the customer and plans to evaluate the table at the customer site.A followup report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Follow-up communication from the customer confirmed the 6mm of drift was measured through a third-party navigation system, had occurred over approximately 4.5 hours, and was in the trendelenburg articulation.The case was supine placement of right neurospace rns lead, and the customer confirmed the case was completed successfully with no adverse effects after the neurosurgeon made adjustments in response to the observed drift in position.Patient information and corrected date of event was provided by the complaint reporter and is reflected in this followup report.An imris customer service engineer assessed the operating room table at the customer site and found no leaks in the hydraulic lines that could have contributed to pressure loss and subsequent drift.Fittings were checked and confirmed to be secure, thus air ingress and interference in the hydraulic function is unlikely.A sample of the hydraulic fluid in the table had been taken and sent out for analysis as part of routine maintenance on the table prior to this event, and results recevied after the drift event showed higher than recommended particle sizing in the fluid.The table's hydraulic fluid was flushed and replaced in response to this finding, and a drift test was performed to confirm no unintended movement after servicing.The probable cause of the drift event is hydraulic line component wear over time leading to particulate contamination of the hydraulic fluid.

• 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: 14957930
• Report Number: 3010326005-2022-00011
• Device Sequence Number: 15182141
• Product Code: FQO
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: Health Professional
• Device Model Number: ORT100
• Device Catalogue Number: 110470-000
• 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: 06/08/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2011
• 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 Age: 21 YR
• Patient Sex: Male
• Patient Weight: 110 KG