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

Model Number ORT100

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

The service engineer performed a hydraulic fluid flush of the table and replaced the roll cylinder.An air bleed procedure was conducted and the table was tested to verify proper function.

Event Description

The patient was on the ort100 table with a slight tilt placed on the table.The table began to drift and continued to drift during the procedure.Anti-tilt support bars that are used on the skytron or bed were utilized by attaching to the side rails of the ort100 table.The procedure was completed successfully.No injuries were reported.

• 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: todd sperling ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 7377342
• MDR Text Key: 103948883
• Report Number: 3010326005-2018-00032
• Device Sequence Number: 1
• Product Code: KXJ
• 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 faci
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: ORT100
• Device Catalogue Number: 110470-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2010
• 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