BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP50

    MDR report key: 20526561 · Received October 24, 2024

    Report

    Report Number
    9610816-2024-00748
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    September 26, 2024
    Report Date
    October 24, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DSI
    PMA / PMN Number
    K151681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS REMOTE CLINICAL SUPPORT (RCS) SPOKE TO THE CUSTOMER BIOMED WHO ALLEGED THAT THE MP50 DID NOT ALARM WHEN THE HEART RATE (HR) WAS LESS THAN THE RATE LIMIT OF 100. THE RCS PROVIDED THE BIOMED THE STEPS ON USING THE AUDIT LOG FILTERS AND SEARCHING. THE RCS ALSO ASKED THE BIOMED TO EXPORT THE AUDIT LOGS AND EXPLAINED HOW TO EXPORT THE LOGS AND WHICH FILTERS TO USE IN THE LOG. THE BIOMED ALSO CHECK THE ALARM SETTINGS ON THE MP50 MONITOR IN THE ROOM AND PROVIDED THE FOLLOWING INFORMATION: VISUAL LATCHING OFF AUDIBLE LATCHING OFF ALARM REMINDER ON REMINDER TIME 3 MINUTES THE RCS FOLLOWED UP WITH THE CUSTOMER BIOMED FOR THE REQUESTED LOGS. THE BIOMED STATED THAT HE DID NOT PULL THE REQUESTED LOGS AND THE ISSUE HAS NOT HAPPENED AGAIN. IT WAS ALSO STATED THAT THE BIOMED CHECK THE MONITOR WITH A SIMULATOR AND REPORTED NO ISSUE. THE RCS STATED THAT THE CASE WAS BEING CLOSED AS THE BIOMED DID NOT PROVIDE THE REQUESTED LOGS AS THE DEVICE WAS FUNCTIONING WITHOUT ISSUE WHEN TESTED WITH A SIMULATOR. THE BIOMED STATED HE WOULD CALL BACK IF THE ISSUE REAPPEARS. THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016 SO NO UDI REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTELLIVUE MP50 DID NOT ALARM WHEN THE HEART RATE (HR) WAS LESS THAN THE RATE LIMIT OF 100. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714494 INTELLIVUE MP50 INTELLIVUE MP50 DSI PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 862116

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown