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 Consequences Or Impact To Patient (2199)

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 operator was unable to hear the patient¿s voice.Philips service determined the gantry microphone was non-functional.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 operator was unable to hear the patient¿s voice.Philips service determined the gantry microphone was non-functional.The customer confirmed that there was no patient impact and no harm as a result of this event.Philips field service engineer (fse) was dispatched to the site for the issue.The fse arrived at the customer site to evaluate the ct system.The fse checked the gantry microphone, as well as, the microphone on the front cover and determined that the audio board and breathing light assembly needed to be replaced.The fse replaced the 4 channel gantry audio board, a usb communication cable, and the breathing light assembly to correct and resolve the malfunction.The system is operational and in clinical use.

• 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: 7228642
• MDR Text Key: 98679834
• Report Number: 1525965-2018-00125
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K060937
• 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: 01/12/2018

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 01/12/2018
• Supplement Dates FDA Received: 04/05/2018
• 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