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 07/22/2022

Event Type  malfunction  

Manufacturer Narrative

The imris customer service engineer was on-site and traced the issue observed with the rotational locking mechanism to the actuator component, which was removed and replaced with a new actuator.The actuator removed from the table was observed to function intermittently and is being returned to the manufacturer for further analysis.The table was functionally tested after component replacement and confirmed to function as intended.

Event Description

During a service visit at a customer site, an imris customer service engineer observed that the intraoperative sliding doors would not open due to the operating room table's rotational position not locking correctly.Upon further assessment the engineer found intermittent function of the actuator component within the table's rotational locking mechanism, and confirmed it had not locked the table's rotational position as intended.There was no patient involvement at the time.

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 ORT200 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: 15251247
• MDR Text Key: 298885842
• Report Number: 3010326005-2022-00013
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

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: Other
• Device Model Number: ORT200
• Device Catalogue Number: 113821-600
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2012
• 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