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

Model Number 728306

Device Problems No Audible Alarm (1019); Device Inoperable (1663)

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

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 gantry microphone was not working in room (b)(6) and they could not hear the patient from the scanning room.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

The customer reported that the gantry microphone was not working in room 1 and they could not hear the patient from the scanning room.The philips field service engineer (fse) confirmed that there was no patient impact and no harm as a result of this event.The philips fse evaluated the ct system and found the gantry microphone was not working.The fse determined that the customer could not hear the patient from the scanning room due to an intercom failure resulting from a malfunction of the breathing light assembly.The fse replaced the breathing light assembly, which contains the gantry microphone, to correct the malfunction.The system is operational and in clinical use.

Manufacturer Narrative

The customer reported the gantry microphone was not working in room 1 and they could not hear the patient from the scanning room.This issue occurred on a brilliance ict system.The philips field service engineer (fse) confirmed that there was no patient impact and no harm as a result of this event.The fse arrived at the customer site and evaluated the ct system.After evaluating the system, the fse was able to confirm the customer¿s allegation, as the gantry microphone was not working.The fse determined that the customer could not hear the patient from the scanning room due to an intercom failure resulting from a malfunction of the breathing light assembly.The fse replaced the breathing light assembly, which contains the gantry microphone, to correct the malfunction.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: 7139279
• MDR Text Key: 95843367
• Report Number: 1525965-2017-00151
• 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,Followup
• Report Date: 11/28/2017

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: 11/28/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 11/28/2017; 11/28/2017
• Supplement Dates FDA Received: 06/21/2018; 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1