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 Poor Quality Image (1408)

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

Event Date 09/04/2023

Event Type  malfunction  

Event Description

It has been reported to philips that during a procedure, the dsa (digital subtraction angiography) device malfunctioned.The focus was faulty, and the images were blurred, and unusable.The device was in clinical use at the time of the event.There was no reported patient or user harm.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to additional information received, the machine was inspected before the digital subtraction angiography (dsa) procedure and was ready for normal use.The patient was taken to the dsa room and the surgery started normally but, mid-procedure, the machine had an issue with the ray focus.The image was blurry and the system could not be used.The patient was transferred to another room to complete the procedure but no patient harm was reported.Philips attempted to schedule having a field service engineer (fse) inspect the system onsite, but the customer never gave approval for onsite evaluation; no device inspection was performed by philips.The customer reported that the device was not repaired and was no longer in use.No further information could be obtained from the customer despite multiple attempts.The codes were updated based on the investigation outcome.On-site evaluation not approved; no response received for further information.

• 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: 17929437
• MDR Text Key: 325565557
• Report Number: 3003768277-2023-05595
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054202
• UDI-Public: 00884838054202
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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

• 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: 09/26/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2017
• 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