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

Model Number 728243

Device Problem Device Operates Differently Than Expected (2913)

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

The customer reported the operator was not able to hear the patient; this was confirmed by philips field service engineer (fse).If the operator is unable to hear the patient due to a failed ct box 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 operator was not able to hear the patient.The customer stated that they had already adjusted the volume but the problem persisted and requested a service visit.This issue occurred on a brilliance big bore oncology 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) arrived at the customer site to evaluate the ct system and determined that the intercom board (microphone board) had failed.The fse replaced the microphone board to resolve the malfunction.The system is operational and in clinical use.This event has been determined not to be a reportable event.

• Brand Name: BRILLIANCE BIG BORE ONCOLOGY
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 7146430
• MDR Text Key: 95830506
• Report Number: 1525965-2017-00157
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K033357
• 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: 12/04/2017

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: 728243
• Device Catalogue Number: NCTB104
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 12/04/2017
• Supplement Dates FDA Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1