MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS ORT200 OPERATING ROOM TABLE

Model Number ORT200

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

An imris customer service engineer (cse) was on-site to resolve the issue.The cse discovered that the roll cylinder failed to keep back pressure on the line and the cause appeared to be a cylinder valve failure.The cse replaced the roll cylinder with a new one and performed drift testing 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 Description

On (b)(6) 2019, the customer reported that the ort200 table was exhibiting a large movement in the roll function.There was no patient involvement.

• Brand Name: IMRIS ORT200 OPERATING ROOM TABLE
• Type of Device: 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: 13476388
• MDR Text Key: 287281329
• Report Number: 3010326005-2020-00004
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORT200
• Device Catalogue Number: 113821-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1