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

Model Number 728231

Device Problems Disconnection (1171); Device Inoperable (1663)

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

Event Type  malfunction  

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported cables were not reconnected following a previous service visit and the system auto-voice feature was not working as a result.However, philips remote support engineer (rse) confirmed that the microphone line in and line out cable was disconnected.As a result, the operator would not be able to hear the patient.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.Based on the further information, this has been determined to be a reportable event.

Manufacturer Narrative

On (b)(6) 2017, the customer reported that the auto-voice feature was not working, nor could the operator hear the patient from the scan room, after a recent service event (pr7502237) to replace a graphics card.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 remote service engineer (rse) instructed the customer to move the host computer to check the audio cable connection status; the audio cables were not connected.The rse instructed the customer how to re-connect the line out audio cable affecting auto-voice and the line in cable from the gantry microphone to the host to 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 64
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: derrick massuri ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 7272613
• MDR Text Key: 100434013
• Report Number: 1525965-2018-00349
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

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: 728231
• Device Catalogue Number: NCTB423
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 12/28/2017
• Supplement Dates FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1