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 Detachment of Device or Device Component (2907)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported to philips that one of the bolts that supports the ceiling arm anchoring system was unscrewed and fell out.The system was in clinical use.No user or patient harm has been reported.Due to the lack of information, we are conservatively reporting this event.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) analyzed the system onsite and verified that one of the bolts that supports the ceiling arch anchoring system has unscrewed and fallen out.After performed troubleshooting, fse found that one of the bolts that supports the ceiling arch anchoring system has unscrewed and fallen out.Fse installed corrugated ceiling support.After repairs were completed, 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: 18729091
• MDR Text Key: 335934930
• Report Number: 3003768277-2024-01005
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 02/19/2024
• 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: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2008
• 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