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

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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.Internal cross reference: complaint pr# (b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported the intercom system was faulty.A philips field service engineer (fse) reported the operator was not able to hear the patient at all times.If the operator is unable to hear the patient due to a failed component, there is potential for injury to the patient.This issue has been determined to be a reportable event.This event is currently under investigation.
Additional Manufacturer Narrative
The customer reported that the intercom system was faulty.The user elected to continue use of the system while visually monitoring the patients.A philips field service engineer (fse) confirmed there was no harm as a result of this issue.No rescan/reinjection occurred.No injury resulted.The fse evaluated the system and determined the cause was a malfunction of the front and rear breathing light assembly board located in the gantry.The fse replaced both the front and rear breathing light assembly to resolve the reported problem.The system is operational and in clinical use.This event has been determined not to be a reportable event.

• Brand Name: ICT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 7495055
• Report Number: 1525965-2018-00395
• Device Sequence Number: 1949278
• Product Code: JAK
• UDI-Device Identifier: 00884838059481
• UDI-Public: (01)00884838059481
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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
• Operator of Device: Health Professional
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1