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	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An imris customer service engineer (cse) was on-site to resolve the issue.Components inside the ort200 table's hydraulic system wore over time and contributed particulate matter to the hydraulic system, potentially impacting the function/performance of the internal valves/seals.The cse flushed and filtered the hydraulic fluid in the table.Furthermore, a new check valve was installed and the table was drift tested to verify proper function.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 a 14-hour ablation procedure on (b)(6) 2021, the customer observed that the ort200 table exhibited some drift.There was no patient harm or user injury reported due to the event.

• 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: kwaku amoah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13451188
• Report Number: 3010326005-2021-00008
• Device Sequence Number: 5892845
• Product Code: KXJ
• UDI-Device Identifier: 00857534006349
• UDI-Public: 00857534006349
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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: ORT200
• Device Catalogue Number: 114148-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• 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