MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS T2X OR TABLE V2 (ORT100); OPERATING ROOM TABLE

Model Number ORT100

Device Problem Positioning Problem (3009)

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

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

This table was manufactured in 2010 and had been in use for 8 years.An internal capa ((b)(4)) was initiated for drift observed in ort100 tables.The table in question was repaired using corrective and preventive actions implemented in the capa.The hydraulic fluid was flushed and the in-line filter was replaced.After the hydraulic fluid exchange was performed, an air bleed procedure was conducted.The table was then drift tested to verify proper function.

Event Description

During a patient procedure, it was observed that the ort100 operating room table was drifting slightly to the right.The level of drift was observed via the catheter bag not being level.Or personnel re-leveled the table approximately every half hour during the procedure and were able to complete the procedure successfully.There were no injuries sustained by the patient.

• Brand Name: IMRIS T2X OR TABLE V2 (ORT100)
• 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: 7188170
• MDR Text Key: 97876641
• Report Number: 3010326005-2018-00001
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• 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: 110470-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2010
• 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