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

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 (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 intercom system failed.The philips field service engineer (fse) confirmed that the operator could not hear the patient at all times.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 intercom system failed and as a result, the doctor could not hear the patient voices from ct box.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) arrived at the customer site on (b)(6) 2018 to evaluate the ct system.The fse tested the breathing light board (assembly) and determined that it was not functioning.The fse replaced the breathing light assembly to correct and resolve the issue.The system was tested successfully and 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: 7373347
• MDR Text Key: 103808365
• Report Number: 1525965-2018-00380
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838059474
• UDI-Public: (01)00884838059474
• 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: 03/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• 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
• Date Manufacturer Received: 03/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1