MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT300 OPERATING ROOM TABLE

Model Number	ORT300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The leak was discovered during a detailed visual inspection with table covers removed, which is performed as part of preventive maintenance.The leak was traced to a union connection to a stainless steel braided ptfe hydraulic hose within the pressurized hydraulic circuit.The service engineer did not observe any functional or performance impact to the table as a result of the leak, which was minor in nature.The hydraulic hose and fitting were replaced and the table preventive maintenance service was completed.
Event or Problem Description
During routine preventive maintenance, an imris service engineer observed leakage of hydraulic fluid from a ptfe hose union within the operating room table.No table functional issues were observed and no reports have been received from the customer relating to the fluid leak.There was no patient involvement.

• 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: 15955521
• Report Number: 3010326005-2022-00018
• Device Sequence Number: 12402571
• Product Code: KXJ
• UDI-Device Identifier: 00857534006462
• UDI-Public: (01)00857534006462
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/09/2022

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: 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: 11/10/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2014
• 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