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

Device Problems Disconnection (1171); 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.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 intercom was not working.The field service engineer (fse) reported the intercom wires were disconnected and the operator could not hear the patient from the gantry microphone.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 working, as the operator was not able to hear the patient and the patient was not able to hear communication from the operator.The customer confirmed that they checked the volume on the ct box and made sure that it was turned up loud enough to hear the patient, but adjusting the volume level did not resolve the issue and onsite service was requested.The philips field service engineer was dispatched to the customer site to evaluate the ct system.The fse removed the rear gantry cone and found that the cables for the microphone and speaker were disconnected.The fse reconnected the cables to the gantry speaker and microphone to resolve the issue; no parts were replaced.There was no report of harm to a patient, operator, or bystander associated with this issue.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
• MDR Report Key: 7168893
• MDR Text Key: 96664679
• Report Number: 1525965-2018-00002
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 12/18/2017
• Supplement Dates FDA Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1