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 06/12/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, the customer reported that the table was exhibiting a significant hydraulic fluid leak.There was no patient harm or user injury reported due to the event.

Manufacturer Narrative

An imris customer service engineer (cse) was on-site to resolve the issue.The hydraulic fluid leak was caused by a ruptured hydraulic fluid line.The cse replaced the line and the table was tested to verify proper function.There were no reports of table drift or patient injury while the table exhibited hydraulic fluid leakage over the period of use.

• 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: kwaku amoah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13476411
• MDR Text Key: 286448513
• Report Number: 3010326005-2018-00044
• Device Sequence Number: 1
• Product Code: KXJ
• UDI-Device Identifier: 00857534006462
• UDI-Public: 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/12/2018

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: ORT300
• Device Catalogue Number: 114093-600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2013
• 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
• Patient Age: 18 YR
• Patient Weight: 68 KG