MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT200 OPERATING ROOM TABLE

Model Number ORT200

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/09/2021

Event Type  malfunction  

Event Description

The customer reported they observed hydraulic fluid on the operating room table covers.No patient involvement or malfunction in the table's operation was reported.

Manufacturer Narrative

An imris customer service engineer went on-site to investigate the reported leakage of hydraulic fluid.The engineer observed pooling of hydraulic fluid inside the table covers and traced the cause of the leak to an o-ring between the table's hydraulic pump housing and fluid reservoir.No patient involvement or malfunction of the table's hydraulic system was reported.The engineer replaced the o-ring and verified table function.This mdr is being submitted outside of the required timeframe as part of remedial action initiated by the manufacturer in response to an internally identified 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: 14739259
• MDR Text Key: 296235755
• Report Number: 3010326005-2022-00009
• Device Sequence Number: 1
• Product Code: KXJ
• UDI-Device Identifier: 00857534006738
• UDI-Public: (01)00857534006738
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/09/2021

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: Health Professional
• Device Model Number: ORT200
• Device Catalogue Number: 113821-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2013
• 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