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

Device Problem Defective Device (2588)

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

Event Date 03/02/2022

Event Type  Injury  

Event Description

The philips iqon scanner decided to pause mid-scan during a stent protocol.Since patient's labs are good, we decided on our own to reinject and rescan since the entire abdominal aorta and stent is not visualized in the first pass.Set up for a second attempt, reinjected and rescanned.The scanner made it through a little bit further than the first attempt, but again stopped before completing the pass.It then took over a minute for it to regroup and allow us to do any additional scans so we figured we should scan the delay pass through the stent.It completed that entire planned pass at least.Due to this malfunction, a 2nd injection of iv contrast medication was needed along with additional radiation to the patient that would otherwise have been unnecessary.This is not the first time that we've had major malfunctions like this on this scanner.My coworkers and i do not trust this scanner and until philips can figure out what is causing these scans to pause mid-injection and fix it, we do not feel comfortable scanning patients with contrast exams.We have also postponed any major procedures since we do not feel comfortable having a patient with a needle placed in them during a biopsy and have the scanner fail mid-procedure.Fda safety report id# (b)(4).

• Brand Name: IQON CT SCANNER
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
• MDR Report Key: 13691899
• MDR Text Key: 286890723
• Report Number: MW5107921
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other