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

Model Number ALLURA XPER FD20

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the patient fell off of the table during a slide/transfer.It was noted that the mattress was narrow and not secured to the device's table with velcro.The device was in clinical use at the time of the event.No harm to the patient or user was reported.Additional information received from the philips account manager indicated that the patient is well.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The investigation identified that at the end of a planned treatment procedure, during transfer off of the allura xper fd20 system table, the patient fell.The procedure was completed as planned.No harm to the patient nor users was reported.Information obtained during the investigation established that the patient was over 80kg.Philips has been informed that the customer is using velcro to secure the mattress to the table.The device has been returned to clinical use.The codes were updated based on the investigation outcome.Health impact code was corrected.

• Brand Name: ALLURA XPER FD
• 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: 18180366
• MDR Text Key: 328611708
• Report Number: 3003768277-2023-06386
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054202
• UDI-Public: 00884838054202
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K162859
• 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: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20
• Device Catalogue Number: 722028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• 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