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

Model Number ORT300

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hemorrhage/Bleeding (1888); No Code Available (3191)

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.

• Brand Name: ORT300 OPERATING ROOM TABLE
• Type of Device: RADIOLOGIC 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 Key: 6687124
• MDR Text Key: 79087418
• Report Number: 3010326005-2017-00003
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K083137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: ORT300
• Device Catalogue Number: 114093-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 22 MO
• Patient Weight: 14