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

Model Number 728235

Device Problem Device Stops Intermittently (1599)

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

Event Type  malfunction  

Manufacturer Narrative

Internal cross reference: complaint (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 that the microphone malfunctioned and autovoice worked intermittently.Philips service determined that an audio connection at the host computer had failed.This failed connection could prevent the operator from hearing the patient via the intercom.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

On (b)(6) 2017, the customer reported that the gantry microphone had malfunctioned and auto voice worked intermittently.The customer confirmed with the philips helpdesk (when this issue was reported) that there was no patient impact and no harm to a patient, operator or bystander as a result of this event.The philips field service engineer (fse) evaluated the system and determined that an audio connection at the rear of the host pc had failed, which caused the intermittent microphone and autovoice failures.The fse made a mechanical adjustment to the connection to resolve the issue; no parts were replaced.The system is operational and in clinical use.

• Brand Name: BRILLIANCE 40
• 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: 7200819
• MDR Text Key: 97675419
• Report Number: 1525965-2018-00010
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728235
• Device Catalogue Number: NCTA402
• 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: 12/19/2017
• 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