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 Display or Visual Feedback Problem (1184)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

It was reported to philips that there was a problem with the monitor.No harm was 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.Customer reported there was a monitor fluoroscopy problem.Remote service engineer (rse) called and analyzed the system.Rse suggested onsite service.Customer refused the quotation of onsite service from philips.Since the quotation has been cancelled and no service has been provided from the philips.To date, no further information was received.The codes were updated based on the investigation outcome.

• 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: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17490904
• MDR Text Key: 321321878
• Report Number: 3003768277-2023-04350
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054202
• UDI-Public: 00884838054202
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K161563
• 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

• 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
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• 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