BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 21272647 · Received January 30, 2025

    Report

    Report Number
    3003768277-2025-000855
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 31, 2022
    Report Date
    February 1, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059054
    PMA / PMN Number
    K130638
    Removal / Correction Number
    3003768277-12/08/2023-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4) AND IS RELATED TO AND OCCURRED PRIOR TO C&R#: 3003768277-08/04/2023-005-C.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4)) AND IS RELATED TO AND OCCURRED PRIOR TO C&R#: 3003768277-08/04/2023-005-C. CORRECTED INFORMATION: REMEDIAL ACTION INITIATED WAS FIRST SENT AS MODIFICATION/ADJUSTMENT WHEN IT SHOULD HAVE BEEN SENT AS "OTHER" RECALL (Z) NUMBER WAS LISTED AS MODIFICATION/ADJUSTMENT WHEN IT SHOULD HAVE BEEN SENT AS 3003768277-12/08/2023-009-C.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT FOOTSWITCH CHORD HAS TEAR IN CABLE. THIS IS CONNECTED TO A LOSS OF IMAGE RELATED TO A ALLURAXPER FD20. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT FOOTSWITCH CHORD HAS TEAR IN CABLE. THIS IS CONNECTED TO A LOSS OF IMAGE RELATED TO A ALLURA XPER FD20. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792018 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838059054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown