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

Model Number ALLURA XPER FD20

Device Problem Power Problem (3010)

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

Event Date 04/16/2023

Event Type  malfunction  

Event Description

It was reported to philips that there was a generator error causing a power issue.The device was inside clinical use at the time of the event.No patient harm was reported.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the system was outside of clinical use when the issue occurred.The philips field service engineer (fse) inspected the system onsite and confirm that generator error.Fse identified the device often reports an error pivot failure.Fse replaced converter 1 and perform high voltage calibration.After replacement of converter1, the system was returned to use in good working order.

• Brand Name: ALLURA XPER FD
• Type of Device: INTERVENTIONAL FLOUROSCOPIC 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: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16821242
• MDR Text Key: 314076253
• Report Number: 3003768277-2023-02537
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• 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: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2011
• 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