MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT300 OPERATING ROOM TABLE

Model Number ORT300

Device Problem Unintended Movement (3026)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

The customer reported that during their morning quality assurance / functional check, the ort300 rotational locking mechanism would not lock the table position into place.No patient was involved at the time; the customer reported an upcoming case planned for the operating room in which the issue occurred was moved into the adjacent operating room.

Manufacturer Narrative

An imris service engineer went on-site the following day 2022-11-02 to assess the operating room table and attempted to lock the table's rotational position into place through the handheld pendant.The engineer was unable to lock the table's rotational position in place, confirming the reported issue.The engineer traced the cause to an actuator component within the rotational locking mechanism, and removed and replaced the actuator component.The table was functionally tested after actuator component replacement and confirmed to function as intended.The actuator is returning to the manufacturer for further investigation.

Manufacturer Narrative

The actuator component was returned to the manufacturer and assessed by the component supplier, who confirmed the reported malfunction due to a switch within the actuator.Internal corrective action has been initiated to further address this issue.

• Brand Name: IMRIS ORT300 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: paul campbell ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 15890744
• MDR Text Key: 307607090
• Report Number: 3010326005-2022-00017
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORT300
• Device Catalogue Number: 114093-600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• 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