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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hearing Impairment (1881)

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

The customer reported that the ct box to the system failed; the operator could not hear the patient and the patient could not hear the operator.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 reported that the ct box to the system failed and the operator could not hear the patient, nor could the patient hear the operator.This issue occurred on an mx 16 slice 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 philips field service engineer (fse) evaluated the ct system and determined that there were two separate issues occurring; one issue associated with the system error and another issue with the ct box.The fse confirmed that there was no sound coming from the ct box; therefore, the operator was not able to hear the patient.The fse replaced the ct control box to correct the malfunction with communication between the patient and operator.The issue with the system error is addressed in complaint record (b)(4).The system is operational and in clinical use.This event has been determined not to be a reportable event.

• Brand Name: MX 16
• 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: 7151822
• MDR Text Key: 96127004
• Report Number: 1525965-2017-00160
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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: 12/05/2017
• 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