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

Model Number CT SPECTRAL 7500

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2023

Event Type  malfunction  

Event Description

The shiny white cover of the ct 7500 gantry reflects the 3rd party lap laser light which displays as a double projection line.This double line projection negatively influences the accuracy of patient or qa phantom setup.There was no reported harm.Based on additional information, there is potential of serious injury if the incorrect laser line was used when marking fiduciary points during a radiation planning procedure caused by the reflection.Therefore, this event is considered reportable.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips engineering has started an investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint (b)(4).

Manufacturer Narrative

Corrected data: the child emdr was created and sent with the incorrect 510k number.This was corrected to reflect the applicable number k203020.The investigation is ongoing and still pending completion.

Manufacturer Narrative

Philips has investigated this complaint.The issue reported was that while using the ct spectral 7500 with the ncte447 oncology essentials package option installed with a third-party external laser system [line acceptance performance (lap)], the lap displayed as a double laser line on the patient surface.The system was in clinical use when this occurred.A philips clinical application specialist (cas) confirmed there was no report of harm to a patient because of the issue.The cas also confirmed that when the customer covered the surface of the gantry cover with a nonreflective material, the double laser line was no longer visible.Philips engineering performed an investigation and determined that the double laser line was caused by a reflection of the horizontal lap laser projecting off the gantry front cover, which has a high glossy surface.A risk assessment was performed with the outcome concluding the risk is acceptable.It is expected that the trained professional will recognize that the laser line is displayed as doubled during patient positioning.At the time this complaint was received, philips did not have enough information to exclude reportability, and as such the complaint was reported.Based on the investigation results, philips concludes that the complaint is not reportable.These codes were updated based on the investigation outcome: problem code health outcome code evaluation results code component code conclusion code.

• Brand Name: IQON SPECTRAL CT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: estelle hilas ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18156492
• MDR Text Key: 328991740
• Report Number: 3015777306-2023-00023
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K203020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CT SPECTRAL 7500
• Device Catalogue Number: 728333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• 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