BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 22113193 · Received May 30, 2025

    Report

    Report Number
    9610816-2025-000425
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 14, 2025
    Report Date
    May 30, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DSI
    PMA / PMN Number
    K150310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE CLINICAL SPECIALIST (RCS) SPOKE WITH BIOMED AND WALKED THROUGH THE PROCESS OF ENTERING THE CONFIGURATION MODE. THE RCS CONFIRMED THE SYSTEM WAS CONFIGURED TO LOW ALARM AND DSAT ALARM DELAY TIME WAS SET TO 20 SECONDS. THE RCS PROVIDED INSTRUCTION TO REVIEW THE CURRENT SETTINGS WITH THE CLINICAL MANAGER AND CHECK THE SYSTEM PERFORMANCE. THE RCS LATER FOLLOWED UP WITH BIOMED; HOWEVER, THEY HAD NOT BEEN ABLE TO CONFIRM OR OBSERVE THE ALARM BEHAVIOR RELATIVE TO THE CONFIGURATION OF THE DEVICE. BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED PROBLEM WAS NOT ESTABLISHED. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE RCS PROVIDED INFORMATION REGARDING SETTINGS AND CONFIGURATION TO RESOLVE THE ISSUE. THE CUSTOMER WAS SATISFIED WITH THE INFORMATION PROVIDED AND INDICATED THE CASE COULD BE CLOSED. THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016 SO NO UDI REQUIRED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MULTI MEASUREMENT SERVER X2 INDICATING THAT WHEN A PATIENT GOES INTO DSAT, THE ALARM IS LOW AND NOT ALARMING FAST ENOUGH. 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
    579017 INTELLIVUE MULTI MEASUREMENT SERVER X2 INTELLIVUE MULTI MEASUREMENT SERVER X2 DSI PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown