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

Model Number ORT100

Device Problem Mechanical Jam (2983)

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

Event Date 02/13/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, the customer reported that the locking mechanism on the ort100 table was not locking or unlocking.There was no patient involvement.

Manufacturer Narrative

An imris customer service engineer (cse) was on-site to resolve the issue.The cse diagnosed the rotational locking mechanism malfunction to a broken linkage pin.The cse removed and replaced the pin and tested the table's locking and unlocking functions to verify proper operation.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
• 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: 13425571
• MDR Text Key: 295864205
• Report Number: 3010326005-2018-00045
• Device Sequence Number: 1
• Product Code: FQO
• UDI-Device Identifier: 00857534006332
• UDI-Public: 00857534006332
• 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: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORT100
• Device Catalogue Number: 110470-000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0975-2018
• Patient Sequence Number: 1