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

Model Number ORT300

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

The leak was discovered during a detailed visual inspection with table covers removed, which is performed as part of preventive maintenance.The leak was traced to a union connection to a stainless steel braided ptfe hydraulic hose within the pressurized hydraulic circuit.The service engineer did not observe any functional or performance impact to the table as a result of the leak, which was minor in nature.The hydraulic hose and fitting were replaced and the table preventive maintenance service was completed.

Event Description

During routine preventive maintenance, an imris service engineer observed leakage of hydraulic fluid from a ptfe hose union within the operating room table.No table functional issues were observed and no reports have been received from the customer relating to the fluid leak.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.; 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: 15955521
• MDR Text Key: 308012746
• Report Number: 3010326005-2022-00018
• Device Sequence Number: 1
• Product Code: KXJ
• UDI-Device Identifier: 00857534006462
• UDI-Public: (01)00857534006462
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/09/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• 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