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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMRIS-DEERFIELD IMAGING, INC. ORT300 OPERATING ROOM TABLE RADIOLOGIC TABLE, PRODUCT CODE KXJ

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IMRIS-DEERFIELD IMAGING, INC. ORT300 OPERATING ROOM TABLE RADIOLOGIC TABLE, PRODUCT CODE KXJ Back to Search Results
Model Number ORT300
Device Problems Mechanical Problem; Unintended System Motion; Unintended Movement
Event Date 06/12/2017
Event Type  Injury  
Manufacturer Narrative

The ort300 table in question was evaluated by the imris-deerfield imaging field service engineer. A small hydraulic fluid leak was observed. While at (b)(6), the field engineer inspected the hydraulic system, cylinders, manifold, and fittings but was unable to determine the exact location of the leak. The table is being returned to imris for further evaluation. When the root cause has been identified, imris shall send a follow-up report. The ort300 table was replaced with a new table on july 10, 2017.

 
Event Description

On (b)(6) 2017, a (b)(6) year old patient was undergoing a cranial procedure. The procedure began at approximately 8:30 am. Around 5 pm, the anesthetist noticed that the ort300 table was lower and that the trendelenburg was not horizontal but tilted downwards towards the patient's head. The surgeon asked if someone had modified the table's position because it was too low. The surgical team then noticed that the table was not in its starting position. They repositioned the table and were able to film the table's descent. The surgery was continued in a non-optimal position for the patient because the table could not keep its position. Approximately at 9:30 pm, the team from imaging began to prepare the patient for mri. They did not see the table change orientation during the 30 minute scan. The patient experienced excessive bleeding from the head. There were no additional physiological consequences experienced by the patient.

 
Manufacturer Narrative

This is a follow-up report. A summary of the root cause analysis follows. The ort300 table was evaluated upon return. Included was a picture of an oil leak and a video from the hospital. The video shows irregular motion when the table is actuated. The lift cylinder appears to be actuated. The table lifts as expected, however, when the actuation is completed, the table appears to relax to a lower position (drops in elevation). Based on the video, initial judgement to explain the issue is air trapped in the hydraulic system. This would cause a momentary instability of the table top position until the air bleeds over the hydraulic cylinder seal until the cylinder piston is supported by the hydraulic oil. An increased probability of trapped air in the hydraulic system is likely since the table had recently undergone a field repair that replaced two hydraulic cylinders. It appears that the field engineer did not completely bleed the air out of the system. When the table was returned, the behavior in the video could not be duplicated. It was concluded that any air trapped in the hydraulic system worked its way out of the system prior to return from the customer. In addition, a small oil leak was identified on the lower fittings of the trendelenburg cylinder. A small drift was present in the trendelenburg motion that appears to correspond with the leak. The drift rate of the table was tested multiple times and tested within specification.

 
Event Description

On (b)(6) 2017, a (b)(6) patient was undergoing a cranial procedure. Later in the procedure, the anesthetist noticed that the table was lower and that the trendelenburg was not horizontal but tilted downwards towards the patient's head. The surgical team then noticed that the table was not in its starting position. They repositioned the table and were able to fild the table's descent. The surgery was continued in a non-optimal position for the patient because the table could not keep its position. The patient experienced excessive bleeding from his head. There were no additional physiological consequences experienced by the patient.

 
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Brand NameORT300 OPERATING ROOM TABLE
Type of DeviceRADIOLOGIC TABLE, PRODUCT CODE KXJ
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 Key6711785
Report Number3010326005-2017-00006
Device Sequence Number1
Product CodeKXJ
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberORT300
Device Catalogue Number114093-000
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/19/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/13/2017 Patient Sequence Number: 1
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