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

Model Number	ORT300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An imris customer service engineer (cse) was on-site to resolve the issue.The entire table was removed from the customer site and returned for further evaluation.The probable root cause of the table drift was traced to contaminants in the hydraulic fluid.This mdr is being submitted outside of the required timeframe as part of remedial action initiated by the manufacturer, in response to internally identified issues regarding failed electronic submissions through webtrader.
Event or Problem Description
During an open brain tumor procedure on (b)(6) 2019, the ort300 operating room table drifted in the left roll position at approximately 8-10 degrees.There was a 20 minute delay in the case while the operating room (or) staff attempted to fit the patient into the scanner without compromising the field or patient position.The operating room staff was able to counterbalance the roll movement with two people leaning on the right side of the or table to keep it leveled while the magnet moved over the patient.There was no patient harm or user injury reported due to the event.

• 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: kwaku amoah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13476371
• Report Number: 3010326005-2019-00034
• Device Sequence Number: 12099524
• Product Code: KXJ
• UDI-Device Identifier: 00857534006462
• UDI-Public: 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection,Replace
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2013
• 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: 60 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG