MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Energy Output Problem (1431)

Patient Problem Death (1802)

Event Type  malfunction  

Manufacturer Narrative

We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr# (b)(4).

Event Description

This complaint has been evaluated based on the information provided.The customer reported that a patient was coding all over the hospital.The philips field service engineer (fse) confirmed the patient had coded multiple times prior to their arrival at the radiology department.The technician set up a c-spine scan, but after 2 minutes of initializing the scan, it appeared to be frozen.The technician used ctrl-alt-del to logout and the received multiple error messages.The patient coded again and cardio pulmonary resuscitation (cpr) was performed successfully.The technician then performed a chest ct scan successfully.However, the patient coded again and was taken to the intensive care unit (icu) where they ultimately passed away.This issue has been determined to be a reportable event.This event is currently under investigation.

Manufacturer Narrative

On 24-dec-2018, the customer reported that a patient was coding all over the hospital.A philips field service engineer (fse) confirmed the patient had coded multiple times prior to arrival at the radiology department.The operator set up for a cervical spine procedure and pressed start to begin.After two minutes of the system initializing to begin the scan, it appeared to be frozen.The operator used ctrl-alt-del to logout; however, multiple error messages were received.The operator acknowledged the errors and finished logging out to restart the system.While the system was restarting, the patient coded again and cardio pulmonary resuscitation (cpr) was performed.When the system recovered, the operator performed a chest procedure successfully.The patient coded again and was taken to the intensive care unit (icu) where they later ultimately expired.The fse confirmed that after the system was recovered by the operator with a system restart, the procedure completed successfully.The fse arrived onsite to evaluate the system.The fse analyzed the system log files and found that there were no recorded faults as alleged by the customer.The fse analyzed a philips proactive monitoring system, diagnostic analysis and reporting (radar) report and noted that the host pc had been rebooted five times in the last two months and was continually on for a long period of time without any restarts.A philips national service specialist (nss) reviewed the information provided and confirmed there were no recorded faults in the system files.The nss instructed the customer to reboot the host pc daily and the common image reconstruction system (cirs) weekly.The system was monitored by the fse; the issue did not recur and there were no additional issues.The system is functional and in clinical use.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: BRILLIANCE AIR 40/64/UCT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 8202887
• MDR Text Key: 131771401
• Report Number: 1525965-2018-00426
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/24/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/24/2018
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1