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 05/25/2023

Event Type  malfunction  

Event Description

The customer reported that during the set-up phase of a surgical procedure the imris ort200 operating room table would not lock into position after it was unlocked for rotation.This caused a delay in the start time of the procedure and a patient was on the table at the time of the event.The patient was transferred to an alternate non-imris operating room table that was brought into the operating room.The customer reported interruption to workflow and additional time under anesthesia for the patient, and that the case was completed as intended.No further patient or procedural complications were reported.No intra-operative imaging was planned for the case.

Manufacturer Narrative

An imris service engineer assessed the operating room table at the customer site and isolated the cause to an acutator 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.Internal corrective action has been initiated by the manufacturer to further address this issue.

• 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 (Section G): 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: 17192251
• MDR Text Key: 317770569
• Report Number: 3010326005-2023-00006
• Device Sequence Number: 1
• Product Code: KXJ
• UDI-Device Identifier: 00857534006738
• UDI-Public: (01)00857534006738
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/23/2023

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: 113821-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 73 KG