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 07/30/2022

Event Type  malfunction  

Manufacturer Narrative

The suspected source of the fluid leak is a valve component within the hydraulic manifold.No hydraulic pressure loss or impact on table function has been observed.A followup report will be submitted once the investigation is complete.

Event Description

During routine preventive maintenance, an imris customer service engineer observed several small drops of hydraulic fluid on outside of the hydraulic lines of the ort300 operating room table.No issues were reported or observed with respect to hydraulics controlled table functions.There was no patient involvement.

Manufacturer Narrative

An imris customer service engineer made multiple site visits to address the preventive maintenance finding of a small hydraulic fluid leak from the operating room table.The source of the leak was not definitively determined, at a followup visit no fluid outside the hydraulic system was observed.Multiple suspected hydraulic system components were replaced as a preventive measure, including a flow control valve, a hose, and multiple fittings and unions.Hydraulic system pressure and fluid levels were measured to be within specification, and weighted drift testing was performed with passing results.No impact to table function was reported or observed.

• 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: 15316924
• MDR Text Key: 298886122
• Report Number: 3010326005-2022-00014
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2022

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: ORT300
• Device Catalogue Number: 114093-000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/30/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 07/30/2022
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1