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

Model Number 728306

Device Problem Device Inoperable (1663)

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 the doctor could not hear the patient in the operation room from the scan room due to a failed breathing light assembly.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 be en determined to be a reportable event.This event is currently under investigation.

Manufacturer Narrative

The customer reported on 10-jan-2018 that the doctor could not hear the patient in the control room from the scanning room during a procedure.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 field service engineer (fse) was dispatched to the customer site to evaluate the ct system.The fse confirmed the customer¿s allegation and determined that the microphone in the gantry microphone breathing light assembly had failed.The fse replaced the breathing light assembly to resolve the issue.The failed part was disposed of and not available for evaluation.The system is operational and 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
• MDR Report Key: 7212395
• MDR Text Key: 98192004
• Report Number: 1525965-2018-00016
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K060937
• 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: 01/11/2018

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: 728306
• Device Catalogue Number: NCTC780
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1