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	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An imris customer service engineer (cse) went on-site to investigate the operating room table, and found that the actuator component in the rotational locking mechanism had failed.The root cause of the rotational lock not functioning to lock the table position is the actuator component malfunction, which is traced to design.The actuator component was replaced with an actuator with an upgraded design, as part of field corrective activities being undertaken to address ort300 rotational locking mechanism malfunctions with the previous actuator design.
Event or Problem Description
It was reported the ort300 operating room table failed to lock into place, was non-functional, while in use.No patient impact or procedural consequence was reported.

• 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: 13467544
• Report Number: 3010326005-2022-00003
• Device Sequence Number: 17349986
• Product Code: KXJ
• UDI-Device Identifier: 00857534006356
• UDI-Public: 00857534006356
• 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
• Remedial Action: Recall,Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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: 114093-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 02/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2585-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown