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

Model Number ORT300

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 06/24/2023

Event Type  malfunction  

Manufacturer Narrative

The imris customer service engineer addressed the issue on-site.A fitting securing a pressurized hydraulic line connection was identified as the source of the leak and was adjusted and tightened.The cse measured the hydraulic fluid level in the operating room table and confirmed it was within specification.The table was functionally tested and no functional issues were present or previously reported by the customer.The cse inspected the table on a follow-up site visit and confirmed the absence of any fluid leaks.A follow-up report will be submitted upon completion of the investigation.

Event Description

During routine preventive maintenance, an imris customer service engineer observed drops of hydraulic fluid outside of the hydraulic lines of the ort300 operating room table.The source of the leak was traced to a fitting on a pressurized hydraulic line.No table functional issues were identified during subsequent testing.There was no patient involvement.

• Brand Name: IMRIS ORT300 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: 17375352
• MDR Text Key: 319866264
• Report Number: 3010326005-2023-00008
• Device Sequence Number: 1
• Product Code: KXJ
• UDI-Device Identifier: 00857534006356
• UDI-Public: 00857534006356
• 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
• Report Date: 07/21/2023

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: Other
• Device Model Number: ORT300
• Device Catalogue Number: 114093-000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/24/2023
• Initial Date FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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