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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 Movement
Event Date 04/03/2017
Event Type  Injury  
Manufacturer Narrative

Based on a review of trending analysis of customer complaints and service calls, this incident appears to be an isolated incident. The device history record for the or table was reviewed and no discrepancies were observed. The field service engineer visited the customer site to inspect the table and perform further investigation into the root cause. The issue of drift was verified in the trendelenburg cylinder. A replacement trend cylinder was installed. The table was functionally tested to verify proper operation, including a 10 hour overnight drift test with 25 kg placed at the end of the back section. The drift test result passed with 0. 0 degrees of drift. The trendelenburg cylinder is being returned to imris and will subsequently be shipped to the vendor for further root cause investigation.

 
Event Description

During a surgical procedure for cerebral arterial venus malformation (avm) on (b)(6) 2017, the chief nurse and the surgeons noticed that the patient was bleeding excessively and intracranial pressure had dropped. The surgeons elected to not perform intra-operative imaging due to the swollen cerebellum. They closed the skin quickly without properly closing the skull and the dura mater. As they were preparing the room for post-op imaging after the case, they observed that the or table was tilted head downward. Post-surgery (at home), the child had a cerebral spinal fluid leak and returned to the hospital for a prolonged stay. The cerebral spinal fluid leak recurred two more times because the dura mater and not been closed. The leaks were repaired with stitches on both occurrences. On (b)(6) 2017, the patient underwent a second operation to close the dura mater, skull and skin. The surgery went well according to the or staff. The impact on the patient's neurological functions are undeterminable at this point.

 
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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 Key6687124
Report Number3010326005-2017-00003
Device Sequence Number1
Product CodeKXJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Repair
Type of Report Initial
Report Date 05/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2017
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? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2017
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: 07/05/2017 Patient Sequence Number: 1
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