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

Model Number ALLURA XPER FD10

Device Problem Radiation Output Failure (4027)

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

Event Date 04/15/2024

Event Type  malfunction  

Event Description

It was reported to philips that the device's wired footswitch intermittently fails to trigger exposure.The device was in clinical use at the time of reported event.No harm was reported to philips.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the system was in planned non-emergency treatment, and the procedure was completed by using a hand switch from control room.A philips remote service engineer (rse) checked the system remotely and reviewed the log file which confirmed that there was footswitch issue.A philips field service engineer (fse) inspected the system onsite and confirmed that the footswitch did not respond intermittently.The fse replaced the wired footswitch.After the replacement, the system was returned to use in good working order.The codes were updated based on the investigation outcome.Evaluation method code was corrected.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19214101
• MDR Text Key: 341402105
• Report Number: 3003768277-2024-02530
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059030
• UDI-Public: 00884838059030
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K130842
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2024

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 FD10
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 06/11/2024
• Supplement Dates FDA Received: 06/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2013
• 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