BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 21460176 · Received February 25, 2025

    Report

    Report Number
    9610816-2025-000141
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 31, 2025
    Report Date
    August 12, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DSI
    UDI-DI
    00884838000261
    PMA / PMN Number
    K150310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: REPORTING INSTITUTION PHONE: #(B)(6). E1: REPORTER PHONE: #(B)(6). PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT HAS BEEN DETERMINED TO BE A DUPLICATE OF MFR 9610816-2025-000138. PLEASE SEE MFR 9610816-2025-000138 FOR THE COMPLETE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A SPEAKER FAILURE ALARM DISPLAYED. IT IS UNKNOWN IF THE DEVICE WAS ABLE TO PRODUCE AN AUDIBLE SOUND. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464201 INTELLIVUE MULTI MEASUREMENT SERVER X2 INTELLIVUE MULTI MEASUREMENT SERVER X2 DSI PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH M3002A 00884838000261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown