MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT100 OPERATING ROOM TABLE

Model Number	ORT100
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the rotational locking mechanism in an ort100 operating room table was jammed, such that it would not lock or unlock.The rotational lock is controlled through use of a foot pedal, which was difficult to depress and mechanically engage the rotational locking mechanism.No patient involvement was reported, the issue was observed during a qa check.
Additional Manufacturer Narrative
Imris engineer has visited the customer site and confirmed the rotational locking mechanism was seized.A followup report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
Imris engineer has visited the customer site and confirmed the rotational locking mechanism was seized.A followup report will be submitted once the investigation is complete.
Event or Problem Description
It was reported the rotational locking mechanism in an ort100 operating room table was jammed, such that it would not lock or unlock.The rotational lock is controlled through use of a foot pedal, which was difficult to depress and mechanically engage the rotational locking mechanism.No patient involvement was reported, the issue was observed during a qa check.
Additional Manufacturer Narrative
The rotational locking mechanism is controlled by the user through a foot pedal at the base of the operating room table.An imris engineer found the foot pedal assembly was bent as a result of customer interaction with the mechanism, which is likely a result of the user attempting to lock the table position in place when the table rotational alignment was not correct at zero degrees.It is possible that fluid ingress from poor fluid management, or binding of foot pedal components, could have caused increased difficulty in using the foot pedal and led to deformation of the mechanism.The locking pin that mechnically locks the rotational movement was found to be intact.Preventive maintenance prior to this event did not observe difficulty in locking the table's rotational position or using the foot pedal.The foot pedal locking mechanism was replaced in the table and its function verified.

• Brand Name: IMRIS ORT100 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 Contact: paul campbell ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13200899
• Report Number: 3010326005-2022-00001
• Device Sequence Number: 5125649
• Product Code: FQO
• UDI-Device Identifier: 00857534006332
• UDI-Public: 00857534006332
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: ORT100
• Device Catalogue Number: 114070-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 01/08/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2011
• 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