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

Model Number	728332
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 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 operator could not hear the patient from the imaging 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.
Additional Manufacturer Narrative
The customer reported that the operator could not hear the patient from the scan room.This occurred on an iqon spectral ct system.There was no report of harm as a result of this issue.The philips field service engineer (fse) went to the site to investigate the reported problem.The fse evaluated the system and was able to confirm the customer¿s allegation.The fse stated that the auto-voice and manual commands going to the scan room could still be heard.The fse tried turning the volume on the ct box all the way up to hear from the scan room, but sound still could not be heard.The fse determined that a failed breathing light assembly was the cause for the loss of communication.The fse replaced the breathing light assembly and the system was returned to full functionality.There was no report of harm as a result of this reported issue.The system is in clinical use.

• Brand Name: IQON SPECTRAL CT
• 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: 7437168
• Report Number: 1525965-2018-00392
• Device Sequence Number: 11275836
• Product Code: JAK
• UDI-Device Identifier: 00884838059542
• UDI-Public: (01)00884838059542
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133674
• 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): 03/26/2018

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
• Device Model Number: 728332
• Device Catalogue Number: 728332
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1