MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT200 OPERATING ROOM TABLE

Model Number	ORT200
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during set-up of a non-imaging case, the operating room table's rotational locking mechanism failed to unlock table movement until several attempts were made.After the table unlocked rotational position and the table was rotated to the desired position, the mechanism subsequently failed to lock table movement until after several attempts were made.The customer reported there was a patient on the table during the event, and that no harm or impact to the surgical procedure occurred as a result of the intermittent mechanism function.
Additional Manufacturer Narrative
An imris serivce engineer assessed the operating room table at the customer site on 2023-07-24 and isolated the cause of the malfunction to the acutator component within the table's rotational locking mechanism.The service engineer removed and replaced the actuator component and functionally tested the table after the repair.The actuator was returned to the manufacturer and an internal corrective action has been initiated to further address this issue.Multiple attempts to obtain patient demographic information were made and no further information was provided.

• Brand Name: IMRIS ORT200 OPERATING ROOM TABLE
• Common Device Name: OPERATING ROOM TABLE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: paul campbell ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; 7632036344
• MDR Report Key: 17577709
• Report Number: 3010326005-2023-00009
• Device Sequence Number: 15553604
• Product Code: KXJ
• UDI-Device Identifier: 00857534006349
• UDI-Public: (01)00857534006349
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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: ORT200
• Device Catalogue Number: 114148-000
• 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: 07/21/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown