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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hearing Impairment (1881)

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.(b)(4).

Event Description

The customer reported that gantry microphone has failed and nothing can be heard from the ct box speaker.If the operator is unable to hear the patient due to a failed microphone, there is potential for injury to the patient.This issue has been determined to be a reportable event.This event is currently under investigation.

Manufacturer Narrative

The customer reported that the gantry microphone had failed and nothing could be heard from the ct box speaker.This issue occurred on a brilliance 64 ct system.The customer confirmed with the philips help desk that there was no patient impact and no harm as a result of this event.The philips field service engineer (fse) proactively ordered two gantry microphone assemblies to replace both the front and rear gantry microphones to correct the malfunction.The fse arrived at the customer site replaced both microphones successfully.The system is operational and in clinical use.This event has been determined not to be a reportable event.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: 7151986
• MDR Text Key: 96127126
• Report Number: 1525965-2017-00161
• 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: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 12/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1