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

Model Number	ORT100
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018, an ort100 table was used to perform a procedure on a patient in a lateral position.The patient's body was very close to the edge of the table and was secured to the table with large rolls of tape.The nurse proceeded to scan the patient and noticed the table was tipped at an angle away from the doors of the suite.The nurse presumed that the surgeon had requested the angled position.The nurse flattened the table and continued to scan the patient however;the images were poor because it appeared as if the patient was moving during the scan.Upon returning to move the scanner off the patient, the anesthetist and the nurse noticed that the table had tilted again towards the side where the majority of the patient's weight was located.There was no patient injury reported due to the event.
Additional Manufacturer Narrative
An imris customer service engineer (cse) was on-site to resolve the issue.The cse evaluated the table and observed table drift in the roll position.The cse replaced the roll cylinder, bled the hydraulics, and performed a 24 hour drift testing to verify proper function.The degradation of the o-ring seal inside the roll cylinder appeared to be the underlying cause.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 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 (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: 13428236
• Report Number: 3010326005-2018-00038
• Device Sequence Number: 5328177
• Product Code: FQO
• UDI-Device Identifier: 00857534006332
• UDI-Public: 00857534006332
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Remedial Action: Repair,Inspection,Recall
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

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: ORT100
• Device Catalogue Number: 110470-000
• 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: 08/30/2018
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2010
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0646-2019
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 85 KG