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

Model Number 728332

Device Problem Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The investigation of this event is currently in process and has not yet been completed.A final mdv will be submitted at the completion of the investigation.

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 operator could not hear the patient due to a failed 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 reported that the operator could not hear the patient due to a failed gantry microphone.The customer confirmed that there was no patient impact and no harm as a result of this event.The philips field service engineer (fse) went to the customer site to evaluate the ct system and perform corrective maintenance.The fse determined that the operator could not hear the patient due to a failed breathing light assembly and a failure of the gantry microphone assembly front panel.The fse replaced the breathing light assembly and gantry microphone assembly front panel to correct and resolve the issue.There was no report of harm to a patient, operator, or bystander as a result of this event.The system is operational and in clinical use.

• Brand Name: IQON SPECTRAL CT
• 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: 7139345
• MDR Text Key: 95836082
• Report Number: 1525965-2017-00152
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133674
• 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: 11/28/2017

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: 728332
• Device Catalogue Number: 728332
• 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: 11/28/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• 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