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

Device Problem No Audible Alarm (1019)

Patient Problem Extravasation (1842)

Event Type  Injury  

Manufacturer Narrative

Internal cross reference: complaint pr# (b)(4).

Event Description

The customer reported that during a patient scan with contrast injection, the patient called for assistance.However, the microphone was not loud enough and the technologist could not hear the patient call; the contrast extravasated into the tissue.The patient underwent surgery to remove the compartment that had developed due to the extravasation.

Manufacturer Narrative

The customer reported that on (b)(6) 2017, while performing a clinical bolus tracked ct abdomen procedure with contrast injection and utilizing a medrad power injector, a patient called for assistance.However, the microphone was not loud enough and the technologist could not hear the patient call for assistance and the contrast extravagated into the tissue.The operator recognized the absence of contrast media in the vessels and anatomy and immediately aborted the scan.The patient was tended to, the iv access was removed, and a heparin bandage was applied.A rescan was then performed without an additional contrast injection.The patient was later taken to surgery to remove the excess fluid under the skin.The customer reported that they turned the volume of the microphone all the way down due to background noise from system operation.The customer stated that this issue occurred due to their own fault.Philips was notified on 18-oct-2017.A philips field service engineer (fse) confirmed the incident.The fse was dispatched to the customer site to evaluate the ct system.The fse arrived at the customer site on 27-oct-2017.The fse confirmed the ct system has 4 microphones for patient communication.Two microphones were tested and found to have low communication/sound and were also covered by some background noise.The fse did not report finding any issues with the additional 2 microphones; however, all 4 gantry microphones were proactively replaced during the corrective maintenance visit.Two gantry panel microphones and 2 gantry microphone assemblies were replaced.The communication was confirmed to be working after the microphones were replaced.The fse also confirmed the customer has the ability to adjust the sound level for the system intercom at the ct box.The fse explained that the microphones were deposited/scrapped at the customer site; therefore, the parts could not be returned for further evaluation and/or failure analysis.In this case, the customer stated the volume was turned all the way down because of the existing background noise from system operation and this issue occurred due to their own fault.On 14-may-2018 the on-site biomedical engineer confirmed with the philips operation manager the ct system did not cause or contribute to the extravasation.The system is operational and in clinical use.This event has been confirmed to no longer be a reportable event and there was no malfunction of the ct system.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: 6966101
• MDR Text Key: 89865472
• Report Number: 1525965-2017-00020
• 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: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 70