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

Model Number 728306

Device Problem No Audible Alarm (1019)

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.Internal cross reference: complaint pr# (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 it was difficult to hear the patient.It was confirmed with the philips field service engineer (fse) the customer could not hear the patient from the gantry microphone.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.

Manufacturer Narrative

The customer reported on (b)(6) 2018 that the operator could not hear sound coming from the microphone gantry at all times.However, the customer confirmed that the operator was able to hear the patients thru the open door.Additionally, the customer confirmed that the patient could hear the operator give manual instructions from the ct box and could also hear the auto-voice commands.The customer confirmed with the philips helpdesk (when this issue was reported) that there was no patient involvement and no harm as a result of this event.The philips field service engineer (fse) went to the customer site on 08-mar-2018 to evaluate the ct system.The fse confirmed the customer¿s allegation and found that the microphone had failed.The fse replaced two breathing light assemblies to correct and resolve the issue.The system was handed back to the customer for clinical use.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: 7371213
• MDR Text Key: 103662126
• Report Number: 1525965-2018-00378
• 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: 03/01/2018

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: 03/01/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1