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

Model Number 728306

Device Problem 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.(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 they cannot hear the patient.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 they could not hear the patient.The customer confirmed that there was no patient impact and no harm as a result of this event.The case was dispatched to a philips field service engineer (fse), who evaluated the ct system, and determined that the microphone in the breathing light assembly had failed.The fse replaced the breathing light assembly to resolve the reported issue.The system was handed back to the customer for clinical use after successful completion of the corrective maintenance.The system is operational and in clinical use.

• Brand Name: ICT
• 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: 7110182
• MDR Text Key: 95074582
• Report Number: 1525965-2017-00135
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

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
• Device Model Number: 728306
• Device Catalogue Number: NCTC780
• 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
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 04/04/2018
• 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