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

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

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 they could not hear the patient through the ct box at the console.Philips field service engineer (fse) confirmed the operator was not able to hear the patient at all times.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 audio cannot be heard from the examination room.This occurred on a brilliance ict sp system.There was no report of harm as a result of this issue.The philips field service support manager (fssm) evaluated the system and was able to confirm the customer¿s allegation.The fssm stated that the auto-voice and manual commands going to the scan room could still be heard.The fssm was able to determine that a failed noise reduction audio board assembly and breathing light assembly were the cause for the loss of communication from the examination room.The fssm replaced the noise reduction audio board assembly and breathing light assembly, 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: ICT
• 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: 7550013
• MDR Text Key: 109620089
• Report Number: 1525965-2018-00404
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• 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: 05/07/2018
• 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