MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Improper or Incorrect Procedure or Method (2017)

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.(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 there was no volume in the ct scan room.A philips field service engineer (fse) confirmed that after service, he neglected to reconnect the gantry speaker and microphone.If the operator is unable to hear the patient due to the gantry microphone being disconnected after service, there is potential for injury to the patient.This issue has been determined to be a reportable event.

Manufacturer Narrative

The customer contact reported that the speakers in the ct scan room did not work; the issue was identified that day during a patient scan.The philips field service engineer (fse) was contacted and he confirmed the issue originated when he replaced the anode power module (apm) the previous day.He forgot to reconnect the speaker and microphone in the gantry bore after replacing the apm.The issue with the speakers was resolved by reconnecting the microphone and speaker cables in the gantry bore.No parts were replaced.The issue with the apm replacement is addressed in a separate record, (b)(4).There was no report of harm to a patient, operator, or bystander associated with this issue.The system is operational and in clinical use.Further investigation of this issue determined that this event is not reportable.

• Brand Name: BRILLIANCE AIR 40/64/UCT
• 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: 7155467
• MDR Text Key: 96223099
• Report Number: 1525965-2017-00165
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/14/2017
• 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