IMRIS ORT300 OPERATING ROOM TABLE
Received Jan 17, 2025 · Event occurred Dec 20, 2024
Report 3010326005-2025-00002 · MDR key 21185499
Device
Generic name
Operating Room Table
Manufacturer
Imris - Deerfield Imaging, Inc.Model number
ORT300Catalog number
114093-000
Product problems
- Unintended Movement
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING OPERATING ROOM PREPARATION, THEY WERE NOT ABLE TO LOCK THE ROTATIONAL POSITION OF THE ORT300 REMOVABLE OPERATING ROOM TABLE. THERE WAS NO PATIENT INVOLVEMENT. AN ALTERNATE ORT300 REMOVABLE OPERATING ROOM TABLE WAS UTILIZED IN THE SUBSEQUENT PROCEDURE.
Additional Manufacturer Narrative
AN IMRIS SERIVCE ENGINEER ASSESSED THE OPERATING ROOM TABLE AT THE CUSTOMER SITE ON (B)(6) 2024 AND DETERMINED THE ACUTATOR COMPONENT WITHIN THE TABLE'S ROTATIONAL LOCKING MECHANISM CAUSED THE MALFUNCTION. THE SERVICE ENGINEER REMOVED AND REPLACED THE ACTUATOR COMPONENT AND FUNCTIONALLY TESTED THE TABLE AFTER THE REPAIR. INTERNAL CORRECTIVE ACTION IS IN PROCESS TO FURTHER ADDRESS THIS ISSUE.