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

Model Number 728246

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

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 audio system was not functioning properly.A philips field service engineer (fse) reported the operator was unable to hear the patient at all times.If the operator is unable to hear the patient due to failed audio, 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 they experienced a loss of communication between the console and gantry.This issue occurred on a brilliance 16 air ct system.The customer confirmed with the philips fields service engineer (fse) that there was no patient involvement and no harm as a result of this event.Philips service evaluated the system and determined that there was a loose connection of the power supply in the gantry communication board.This resulted in the communication loss between the console and gantry.The fse secured the connection between the power supply and communication board to resolve the issue; no parts were replaced.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: 7499745
• MDR Text Key: 107987331
• Report Number: 1525965-2018-00396
• 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: 03/11/2018

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: 04/11/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 04/11/2018
• Supplement Dates FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1