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

Model Number ALLURA XPER FD20

Device Problems Unintended System Motion (1430); Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 08/23/2022

Event Type  malfunction  

Event Description

It has been reported to philips that while transferring the patient from the philips equipment table to the mobile bed, the table pivoted.The patient fell to the floor from the table.This incident occurred after procedure was completed.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips performed a gfe in a timely manner but no additional information was received.After investigation is completed a final report will be sent.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the issue occurred at the end of a planned treatment procedure.The patient did not seek medical treatment and no injuries were reported.The philips field service engineer (fse) inspected the system onsite and identified a wear and tear issue with the table's pivot brake.The pivot brake assembly and node interface unit were replaced, and the system was returned to use in good working order.Philips has attempted to obtain patient information.However, the customer has not provided the requested information.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 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15444838
• MDR Text Key: 300257826
• Report Number: 3003768277-2022-00428
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• 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: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2011
• 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