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); Appropriate Term/Code Not Available (3191)

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

Event Date 09/23/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the table pivoted when a patient was being removed from the table.It is unknown what the impact was for the patient.No harm has been reported.We are conservatively reporting this event as the investigation is ongoing.A follow up report will be submitted when further information is received.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the system was in clinical use when the issue occurred.The customer reported table pivot issue.Fse instructed the customer about working of table pivot system.After that, the system was returned to use in good working order.To date, there have been no further reports of this issue.The codes were updated based on the investigation outcome.Device problem code, evaluation method code was corrected.

• 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: 15656914
• MDR Text Key: 304812440
• Report Number: 3003768277-2022-00622
• 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: 10/24/2022
• 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: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2009
• 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