MAUDE Adverse Event Report: IMRIS, INC. ORT200 OPERATING ROOM TABLE; RADIOLOGIC TABLE

Model Number ORT200

Device Problem Loose or Intermittent Connection (1371)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the hospital representative reported that a pin from the ort200 table block (frequently operated by the customer when installing/removing the ort200 table) became loose and was drawn into the magnet, puncturing the image quality phantom and the headrest extension.The event occurred during testing of the phantom on (b)(6) 2014.No injuries were reported.

Manufacturer Narrative

There are three pins or bolts that hold the ort200 table block in place on the floor of the or.One of the pins went missing for two weeks before it was actually reported missing on (b)(4) 2014.Or personnel are trained to always account for each of the three pins when installing the table block, since they are made of ferrous material.When the pin went missing, the mr suite should have been shut down until the pin was located; or personnel neglected to account for the missing pin; therefore, user error contributed to this incident.Imris shall perform further investigation to determine if additional mitigations are necessary to avoid the use error of leaving ferrous pins in the suite.Note: the 510(k) # recorded is for the imris system (neuro iii-sv) installed at (b)(6).

• Brand Name: ORT200 OPERATING ROOM TABLE
• Type of Device: RADIOLOGIC TABLE
• Manufacturer (Section D): IMRIS, INC.; 5101 shady oak road; minnetonka MN 55343 410
• Manufacturer (Section G): IMRIS, INC.; 5101 shady oak road; minnetonka MN 55343 410
• Manufacturer Contact: sanjay shah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036380
• MDR Report Key: 4051806
• MDR Text Key: 4901270
• Report Number: 3003807210-2014-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORT200
• Device Catalogue Number: 113821-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2012
• 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