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

Model Number	ORT200
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during the set-up phase of a surgical procedure the imris ort200 operating room table would not lock into position after it was unlocked for rotation.This caused a delay in the start time of the procedure and a patient was on the table at the time of the event.The patient was transferred to an alternate non-imris operating room table that was brought into the operating room.The customer reported interruption to workflow and additional time under anesthesia for the patient, and that the case was completed as intended.No further patient or procedural complications were reported.No intra-operative imaging was planned for the case.
Additional Manufacturer Narrative
An imris service engineer assessed the operating room table at the customer site and isolated the cause to an 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.Internal corrective action has been initiated by the manufacturer to further address this issue.

• 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 (Section G): 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: 17192251
• Report Number: 3010326005-2023-00006
• Device Sequence Number: 12213902
• Product Code: KXJ
• UDI-Device Identifier: 00857534006738
• UDI-Public: (01)00857534006738
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/23/2023

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: 113821-000
• 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: 05/25/2023
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2013
• 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 Age: 15 YR
• Patient Sex: Male
• Patient Weight: 73 KG