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 System Motion (1430); Unintended Movement (3026)

Patient Problem Hemorrhage/Bleeding (1888)

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.

• 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: 6711785
• MDR Text Key: 80009438
• Report Number: 3010326005-2017-00006
• 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: 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

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 06/13/2017
• Supplement Dates FDA Received: 08/21/2017
• 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): Hospitalization; Life Threatening
• Patient Age: 17 YR
• Patient Weight: 45