MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. INGENUITY CORE128; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 728323

Device Problem Device Inoperable (1663)

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 the speaker in the gantry was not operating after service.This was due to the audio board being left disconnected after preventative maintenance (pm).A philips field service engineer (fse) confirmed the operator was not able to hear the patient at all times.If the operator is unable to hear the patient due to a failed component, 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 there was a communication loss between the operator and the patient.The customer stated that a patient was informed that a scan was about to begin and the patient did not respond.This occurred on an ingenuity core 128 ct system.There was no report of harm as a result of this issue.The philips cse went to the site to investigate the reported problem.The cse evaluated the system and was able to confirm that sound to and from the gantry was not working.The cse determined that the speaker/microphone cable that is mounted to the rear cone was disconnected.The cse reconnected the speaker/microphone cable to resolve the communication problem and the system was returned to full functionality.The system is in clinical use.

• Brand Name: INGENUITY CORE128
• 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: 7515763
• MDR Text Key: 108434012
• Report Number: 1525965-2018-00401
• 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: 04/17/2018

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
• Device Operator: Health Professional
• Device Model Number: 728323
• Device Catalogue Number: III
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1