MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 16 AIR; COMPUTED TOMOGRAPHY X-RAY

Model Number 728246

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.Philips service reported that during a service call, it was found that the gantry microphone was not working.This would prevent a patient from being heard through the ct box.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 philips field service engineer (fse) reported that while onsite (b)(6) 2018 performing a service call for another issue (addressed in pr7548533) found that the gantry intercom microphone was not working.There was a noise at the ct box, but no voice could be heard.This microphone failure would prevent a patient from being heard through the ct box.The fse confirmed the ct system was not in clinical use at the time the failed microphone was found and that the customer did not report an issue with the microphone to philips prior to the incidental finding.The gantry microphone assembly, mems bom was replaced by the fse to correct and resolve the issue.The system is operational and in clinical use.This event has been determined not to be a reportable event.

• Brand Name: BRILLIANCE 16 AIR
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 7228674
• MDR Text Key: 98679037
• Report Number: 1525965-2018-00127
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K012009
• 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: 01/08/2018

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
• Device Model Number: 728246
• Device Catalogue Number: NCTA399
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1