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	11/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation on-site through a third-party representative indicates the malfunction is attributed to the actuator component within the rotational locking mechanism.The manufacturer of the operating room table is working to further investigate the malfunction and collect the actuator component for analysis.
Event or Problem Description
It was reported that during a quality assurance/functional check, the ort200 rotational locking mechanism would not lock the table position into place.No patient was involved at the time.
Additional Manufacturer Narrative
Investigation of similar events by the supplier of the actuator component has identified reported malfunctions due to a switch within the actuator component.The manufacturer of the operating room table has initiated internal corrective action to further address this issue.Based on event details and isolation of the functional issue at the customer site to the actuator component, this event is within scope of the internal corrective action.

• Brand Name: IMRIS ORT200 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: 16031045
• Report Number: 3010326005-2022-00019
• Device Sequence Number: 5643202
• Product Code: KXJ
• UDI-Device Identifier: 00857534006349
• UDI-Public: (01)00857534006349
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: 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: 11/22/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2012
• 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