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

Model Number IQON

Device Problems Product Quality Problem (1506); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

Philips iqon ct scanner repeatedly locks up and freezes during acquisitions.Seems to be related to ct scanner and contrast injector communication issues.These freezes and lockups result in both delays in patient care and i would argue patient injury due to the need to re-inject contrast or re-exposing the patent to x-rays due to system glitches not capturing images from the first scan.When the system was first installed here at the (b)(6) they were having weekly meetings with philips personnel to discuss the variety of extensive problems they have experienced with the system software.It has proven it is not ready for release and use on patients.The weekly meetings eventually dropped off due to exhausting and waste of resources attending meetings to address complaints that were never addressed.We have not been delivered what we paid for in this ct scanner and can't hold philips accountable without outside pressure.The system is riddled with software problems that have been reported multiple times through open cases with philips.The just close the cases with no resolutions and instead offer unacceptable responses such as "well did you reboot the machine." you should be able to easily assess the problems by simply looking at the service history on this product.We have purchased options that have caused consistent system glitches such as the sas options and the sync right option for the ct to interface with the contrast injection but it has been riddled with problems and patched repeatedly.One of the recent patches was for a serious problem where the scanner would not convert the weight entered in the scanner and would transfer the weight incorrectly causing the weight based contrast doses to be much higher than they should.They fixed that problem and have only seemed to exacerbate the communication issues and lockups we are experiencing.We have now been advised by philips to disable the sync right option on the scanner which was one of the reasons this product was purchased.We are at a loss and feel we have bought a lemon with no way out of the constant problems and no real acknowledgement of all these software defects or timeline for correction from philips.Fda safety report id# (b)(4).

• Brand Name: PHILIPS IQON SPECTRAL CT SCANNER
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS / PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
• MDR Report Key: 13002397
• MDR Text Key: 282339343
• Report Number: MW5106028
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IQON
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other