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

Device Problem Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This complaint has been evaluated based on the information provided.The customer reported that the speaker makes noise and the patient and operator are not able to hear each other.If the operator is unable to hear the patient due to a failed component, 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 system was making a noise and the operator could not hear the patient from the scan room.This occurred on a brilliance 64 ct system.There was no report of harm as a result of this issue.The philips field service engineer (fse) went to the site to investigate the reported problem.The fse evaluated the system and logs and was able to confirm the customer¿s allegation.The fse identified an error in the logs that led the fse to determine the common rack console (crc) power distribution module was the cause for the system noise and error that occurred.The noise was a symptom of the power supply beginning to fail and the error occurred when the power supply failed, leading to the ct box shutting down.This led to a loss of communication between the patient and operator.The fse replaced the crc power distribution module and the ct box to resolve the issue and the system was returned to full functionality.The system is in clinical use.This event has been determined not to be a reportable 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
• Manufacturer Contact: derrick massuri ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 7534935
• MDR Text Key: 109009622
• Report Number: 1525965-2018-00402
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2018
• 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