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

Catalog Number III

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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 a crackling noise in the speaker of the ct box.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.

Manufacturer Narrative

The customer reported that on (b)(6) 2017 there was loudspeaker problem, specifically, a crackling noise in the speaker of the ct box.This issue occurred on a philips ingenuity core ct system.The customer confirmed with the philips help desk that there was no patient impact and no harm as a result of this event.The case was dispatched for onsite service support.The philips field service engineer (fse) arrived at the customer site on 14-nov-2017 to evaluate the ct system and confirmed the customer¿s allegation.The fse determined that the speaker inside the ct box assembly was failing and replaced the ct box assembly.The new ct box assembly was tested and confirmed to be working as expected; the system was handed back to the customer for clinical use after the corrective maintenance was completed.The system is operational and in clinical use.

• Brand Name: INGENUITY CORE
• 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: 7096686
• MDR Text Key: 94413190
• Report Number: 1525965-2017-00073
• 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: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: III
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1