MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number ALLURA XPER FD20

Device Problem Mechanical Jam (2983)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the shutters will not open or close.The issue was found during clinical use.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the system was in diagnostic procedure when the issue occurred, and the procedure was completed as planned by using another system.The philips field service engineer (fse) inspected the system onsite and confirmed that the shutter would not open or close.Analysis of the system log file showed that the x-ray generator failed to prepare for acquisition.During troubleshooting, the philips engineer found that the collimator was defective.The fse replaced the collimator.After replacing the collimator, the system was returned to use in good working order.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD20
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18776295
• MDR Text Key: 336191214
• Report Number: 3003768277-2024-01239
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1