MAUDE Adverse Event Report: PHILIPS ELECTRONICS LTD PHILIPS IQON CT SCANNER; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number IQON

Device Problem Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 07/10/2022

Event Type  malfunction  

Event Description

Gantry disconnect issues.The manufacturer was contacted and sent the equipment logs for the timeframe of the reported incident.Upon review of the logs the manufacturer confirmed there was a miscommunication issue, but since it was now working without communication errors, they would be unable to easily troubleshoot any further nor offered any suggestions on what may have caused the errors.Biomedical engineering confirmed with radiology staff no further issues were seen the next two days ((b)(6) 2022) with the equipment.Fda safety report id # (b)(4).

• Brand Name: PHILIPS IQON CT SCANNER
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS ELECTRONICS LTD
• MDR Report Key: 15043802
• MDR Text Key: 296167651
• Report Number: MW5110925
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• 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 Age: 76 YR
• Patient Sex: Male