MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 16 AIR; COMPUTED TOMOGRAPHY X-RAY

Model Number 728246

Device Problem 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 loudspeaker was not working and they could not communicate with the patient.If the operator is unable to hear the patient due to an issue within the audio communication system, 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 loudspeaker was not working and they could not communicate with the patient.The customer confirmed that the ct system was not in clinical use at the time of the event, there was no patient impact, and no harm as a result of this event.The customer reported that the loudspeaker was not working after a recent maintenance visit and announcements could not be made.A philips senior systems engineer stated that during maintenance, this the power supply audio board is disconnected.If the power supply audio board is not reconnected after maintenance, there would be no communication between the operator and the patient.The operator would not be able to hear the patient, and the patient would not hear the operator.The case was dispatched to a philips field service engineer (fse) for onsite support.The fse evaluated the system and determined that a mechanical adjustment was needed to the power supply audio board.The fse adjusted the power supply audio board to resolve the issue; no parts were replaced.The system was handed back to the customer for clinical use after the corrective maintenance was successfully completed.The system is operational and in clinical use.

• Brand Name: BRILLIANCE 16 AIR
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• 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: 7103916
• MDR Text Key: 94809200
• Report Number: 1525965-2017-00106
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K012009
• 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: 11/13/2017

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: 728246
• Device Catalogue Number: NCTA399
• 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: 11/13/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• 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