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	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that on (b)(6) 2023, they unlocked the rotational lock of the ort during a surgical case and could not get the table to lock back in place after rotation to the new position.The ongoing procedure was a drainage for a brain abcess; imaging was not scheduled, planned or requested.The reporter indicated there was no delay in the case or additional time required to complete the procedure, and no impact to the patient.The physician elected to secure the patient with straps and continue the procedure.
Additional Manufacturer Narrative
An imris service engineer went on-site to investigate the reported problem with table function.During the evaluation, the reported problem was unable to be reproduced or observed.The internal components of the table's rotational locking mechanism were assessed and confirmed to be functioning as intended to lock and unlock rotational position.For the reported event, it is possible that inadequate time was allowed through the table's pendant controls for the rotational locking mechanism to produce a locked position.This was communicated while on-site.A supplemental report will be submitted if any additional reportable information is received.

• 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: 16308061
• Report Number: 3010326005-2023-00001
• Device Sequence Number: 6791948
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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: 01/12/2023
• Initial Report FDA Received Date: 02/06/2023
• 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
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 61 KG