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

Model Number ALLURA XPER FD20 OR TABLE

Device Problem Radiation Output Failure (4027)

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

Event Date 04/04/2024

Event Type  malfunction  

Event Description

It has been reported to philips that the wireless foot switch would not work.There was no reported patient or user harm.Due to the lack of information, we are conservatively reporting this event.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to additional information received, the system was not in clinical use when the issue was identified.A philips remote service engineer (rse) inspected the system remotely and confirmed that the wireless footswitch was not working.The customer requested for the part id to order and replace the wireless footswitch.No further information regarding the issue has been provided and no onsite service has been performed by philips it was not requested by the customer.The same issue reoccurred.The philips engineer suggested to replace the wfs and base station in the subsequent case.The codes were updated based on the investigation outcome.

• 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: 19201929
• MDR Text Key: 341286947
• Report Number: 3003768277-2024-02500
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059085
• UDI-Public: 00884838059085
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130842
• 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

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 OR TABLE
• Device Catalogue Number: 722023
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Date Device Manufactured: 08/22/2013
• 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