MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number FD20

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2023

Event Type  malfunction  

Event Description

Started procedure and x-ray equipment stopped working, delaying patient care by 15 minutes.Unit froze during procedure but worked again after rebooting system.There was a patient on the table at the time of the incident.

• Brand Name: ALLURA XPER FD
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; 222 jacobs street; cambridge MA 02141
• MDR Report Key: 16642896
• MDR Text Key: 312300337
• Report Number: 16642896
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FD20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2023
• Device Age: 19 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1