MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS ORT100 OPERATING ROOM TABLE

Model Number ORT100

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

An imris customer service engineer (cse) was on-site to resolve the issue.The o-ring gasket at the ort100 table pump/reservoir was replaced.The table was tested to verify proper function.This mdr is being submitted outside of the required timeframe as part of remedial action initiated by the manufacturer, in response to internally identified issues regarding failed electronic submissions through webtrader.

Event Description

On (b)(6) 2019, the customer reported a hydraulic fluid leak in the ort100 table.The event occurred during daily qa test and there was no patient involvement.

• Brand Name: IMRIS ORT100 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: 13501162
• MDR Text Key: 286584446
• Report Number: 3010326005-2019-00024
• Device Sequence Number: 1
• Product Code: FQO
• UDI-Device Identifier: 00857534006486
• UDI-Public: 00857534006486
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/26/2019

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: ORT100
• Device Catalogue Number: 110470-600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2012
• 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