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	11/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a clear point procedure on (b)(6), 2018, the customer reported that the ort200 table drifted in the trendelenburg position.There was no patient injury reported.
Additional Manufacturer Narrative
An imris customer service engineer (cse) was on-site to diagnose the issue.The cse replaced the roll cylinder in the table and a full hydraulic system flush was performed.The table continued to exhibit some drift in the trend and back tilt functions however, check valves were replaced and a full system flush was repeated.Afterwards, the table was tested and operated within specification.Furthermore, black debris were noticed in the hydraulic fluid reservoir.The cse concluded that some of the debris lodged in the check valves resulted in slow drift.The debris appeared to be degraded seal material.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.

• 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: 13475732
• Report Number: 3010326005-2018-00042
• Device Sequence Number: 3963821
• 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: Other Health Care Professional
• Remedial Action: Inspection,Replace
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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