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

Model Number	ORT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during their morning quality assurance / functional check, the ort300 rotational locking mechanism would not lock the table position into place.No patient was involved at the time; the customer reported an upcoming case planned for the operating room in which the issue occurred was moved into the adjacent operating room.
Additional Manufacturer Narrative
An imris service engineer went on-site the following day 2022-11-02 to assess the operating room table and attempted to lock the table's rotational position into place through the handheld pendant.The engineer was unable to lock the table's rotational position in place, confirming the reported issue.The engineer traced the cause to an actuator component within the rotational locking mechanism, and removed and replaced the actuator component.The table was functionally tested after actuator component replacement and confirmed to function as intended.The actuator is returning to the manufacturer for further investigation.
Additional Manufacturer Narrative
The actuator component was returned to the manufacturer and assessed by the component supplier, who confirmed the reported malfunction due to a switch within the actuator.Internal corrective action has been initiated to further address this issue.

• 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: 15890744
• Report Number: 3010326005-2022-00017
• Device Sequence Number: 12434823
• Product Code: KXJ
• UDI-Device Identifier: 00857534006462
• UDI-Public: (01)00857534006462
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 114093-600
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2013
• 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
• Patient Sex: Unknown