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	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a morning qa, drops of hydraulic fluid were observed at the base of the ort300 operating room table.No issues were reported with respect to hydraulics controlled table functions.There was no patient involvement when the apparent leak was observed.
Additional Manufacturer Narrative
An imris customer service engineer addressed the issue on-site.Upon inspection, the cse confirmed presence of a hydraulic fluid leak and traced it to the connection between a ptfe hydraulic line and the trendelenburg cylinder.The fiting securing the connection was adjusted and tightened.The cse measured the hydraulic fluid level in the operating room table and confirmed it was within specification.No components required replacement and no additional fluid was added to the table.The table was tested to confirm function after the issue was addressed; no table functional issues were observed by the cse or reported by the customer.

• 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: 15080468
• Report Number: 3010326005-2022-00012
• Device Sequence Number: 14482911
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

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: ORT300
• Device Catalogue Number: 114093-000
• 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: 06/21/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2016
• 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