MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. IQON SPECTRAL CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	IQON SPECTRAL CT
Medical Device Problem Code	Program or Algorithm Execution Problem (4033)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was punctate hyperdensities displayed on brain monoe 190kv datasets and resulted in a ct rescan to determine artifact vs pathology.There was no actual harm reported associated with this complaint.Based on the available information, it is unknown if the reported event would be likely to cause or contribute to a death or serious injury if it were to recur.Therefore, this event is being conservatively reported.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips engineering has not completed the investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint (b)(4).
Additional Manufacturer Narrative
Philips has started an investigation.The investigation is still in process and has not yet been completed.A final report will be sent when the investigation is complete.Cross reference: complaint (b)(4).
Additional Manufacturer Narrative
The investigation is still in process and has not yet been completed.A final report will be sent when the investigation is complete.Cross reference: complaint (b)(4).
Additional Manufacturer Narrative
The issue reported was punctate hyperdensities displayed on brain monoe 190kv datasets and resulted in a ct rescan to determine artifact vs pathology.A philips clinical product management specialist stated the artifact had the potential to result in a misdiagnosis, however, in this case, no misdiagnosis or mistreatment occurred.There was no actual harm associated with this complaint.Philips engineering evaluated the digital imaging and communication (dicom) images and raw data and concluded the probable cause of the artifact was due to a suboptimal spectral noise reduction algorithm.Additionally, the conventional images does not display the artifact.Therefore, the site was instructed to revert to the conventional acquisition.Furthermore, as stated in the instructions for use manual for the spectral ct: notice it is always recommended to compare the spectral results with conventional images.Therefore, based on the investigation performed and lower than probability of harm occurring, this event is considered a non-reportable event.The system did not cause or contribute to a death or serious injury, or serious deterioration and would not cause a death or serious injury, or serious deterioration if this event were to recur.

• Brand Name: IQON SPECTRAL CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer Contact: beth johnson ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16983998
• Report Number: 3015777306-2023-00012
• Device Sequence Number: 6957008
• Product Code: JAK
• UDI-Device Identifier: 00884838059542
• UDI-Public: 00884838059542
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K193454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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
• Operator of Device: Health Professional
• Device Model Number: IQON SPECTRAL CT
• Device Catalogue Number: 728332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 04/25/2023; 04/25/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/21/2023; 07/18/2023; 09/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown