BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVUS

    MDR report key: 22236281 · Received June 17, 2025

    Report

    Report Number
    MW5171595
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    April 28, 2025
    Report Date
    June 6, 2025
    Manufacturer
    PHILIPS ULTRASOUND LLC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INTRAVASCULAR ULTRASOUND DID NOT FUNCTION CORRECTLY. SECOND IVUS HAD TO BE OPENED TO PERFORM IMAGING AND COMPLETE CATH. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28521 IVUS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO PHILIPS ULTRASOUND LLC 0303404784

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male