MAUDE Adverse Event Report: IMRIS-DEERFIELD IMAGING, INC. IMRIS T2X OPERATING ROOM TABLE

Model Number T2X

Device Problem Unintended Movement (3026)

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

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

During table drift testing, the service engineer confirmed that the operating room table slowly drifted downward, approximately 1/2 inch over a 40 minute time period.He resolved the drift issue by replacing the hydraulic control manifold.He bled air from the hydraulic system and conducted table drift testing over a 12.5 hour period to verify proper table function.

Event Description

On (b)(6) 2019, the customer reported that the t2x operating room table had drifted trendelenburg downward over a 2-hour laser ablation procedure that occurred on (b)(6) 2019.The procedure was completed successfully.There was no injury to the patient.

• Brand Name: IMRIS T2X 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: 8703960
• MDR Text Key: 148169202
• Report Number: 3010326005-2019-00011
• 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: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/17/2019

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: T2X
• Device Catalogue Number: 109682-600
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2010
• 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