BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21364119 · Received February 12, 2025

    Report

    Report Number
    1218950-2025-000093
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 17, 2025
    Report Date
    February 12, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMOTE SERVICE ENGINEER (RSE) CONFIRMED THAT THE PIC IX WAS ALARMING WITHOUT SOUND. THE RSE WAS ASSISTING THE CUSTOMER BIOMED IN HOW TO VERIFY THE SOUND PROPERTIES ON CONTROL PANEL WHEN THE DEVICE SUDDENLY STARTED REBOOTING BY ITSELF. THE RSE ADVISED THE BIOMED TO RELOAD THE PIC IX SOFTWARE. THE RSE ALSO OFFERED TO DISPATCH A FIELD SUPPORT ENGINEER (FSE), BUT THE BIOMED STATED THAT HE WILL TRY TO FIX IT AND WILL CALL US BACK IF NECESSARY. THE RSE MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER TO FOLLOW UP, BUT THE CUSTOMER DID NOT RESPOND TO ANY EMAIL OR VOICEMAIL ATTEMPTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PIC IX IS ALARMING WITHOUT EMITTING SOUND. 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
    845179 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown