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

Model Number ORT100

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  malfunction  

Event 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.

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.

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)
• Type of Device: 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
• MDR Text Key: 296235442
• Report Number: 3010326005-2022-00011
• Device Sequence Number: 1
• Product Code: FQO
• UDI-Device Identifier: 00857534006332
• UDI-Public: (01)00857534006332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORT100
• Device Catalogue Number: 110470-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 110 KG