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 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

An imris service engineer assessed the operating room table at the customer site the following day (b)(6) 2023 and isolated the cause to an actuator component within the table's rotational locking mechanism.The service engineer removed and replaced the actuator component and functionally tested the table after the repair.The actuator was returned to the manufacturer.An internal corrective action has been initiated by the manufacturer to further address this issue.

Event Description

The customer reported that during a morning quality assurance / functional check, the operating room table's rotational locking mechanism did function properly to lock table position in place.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.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: paul campbell ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; 7632036344
• MDR Report Key: 16778977
• MDR Text Key: 313993983
• Report Number: 3010326005-2023-00004
• Device Sequence Number: 1
• Product Code: KXJ
• UDI-Device Identifier: 00857534006349
• UDI-Public: (01)00857534006349
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/20/2023

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
• Device Operator: Health Professional
• Device Model Number: ORT200
• Device Catalogue Number: 114148-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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
• Patient Outcome(s): Other