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

Note: 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

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported the speaker from the gantry to the console was not working.Philips service verified the operator was not able to hear the patient at all times.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 on (b)(6) 2018 that the operator could not hear the patient in the scan room.The customer confirmed with the philips helpdesk (when this issue was reported) that there was no patient impact and no harm as a result of this event.The philips field service engineer (fse) arrived at the customer site on (b)(6) 2018 to evaluate the ct system.The fse confirmed the customer¿s allegation that no sound could be heard from the ct gantry to the ct box.The fse determined that the microphone board failed; the volume on the ct box had no issue.The fse replaced the breathing light assembly, which includes a microphone module along with the right front microphone to gantry audio board cable and left front microphone to gantry audio cable 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: 7278171
• MDR Text Key: 100520048
• Report Number: 1525965-2018-00352
• 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: 01/24/2018

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
• 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: 01/24/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1