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

Model Number ALLURA XPER FD20 OR TABLE

Device Problems Contamination (1120); Mechanical Problem (1384); Particulates (1451); Application Program Problem (2880)

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

Event Date 08/03/2022

Event Type  malfunction  

Event Description

During elective bilateral extracranial neuro embolization in interventional radiology room 1.Equipment malfunction -pt under ga there was a microcatheter with particle embolic in use.Fluoroscopic imaging was still available, however higher equipment functions needed were unavailable due to ongoing disc space issue.Clinical engineering was called with high importance.The procedure was completed without further incidence.

• 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: 16634926
• MDR Text Key: 312243898
• Report Number: 16634926
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/22/2023,09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20 OR TABLE
• Device Catalogue Number: 722035
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Date Report to Manufacturer: 03/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male