BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE PERINATAL ADV SYS, INTEG ED

    MDR report key: 24694978 · Received March 25, 2026

    Report

    Report Number
    9610816-2026-100594
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 26, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    UDI-DI
    00884838034532
    PMA / PMN Number
    K100420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED BY A PHILIPS REMOTE SERVICE ENGINEER (RSE) WHICH INCLUDED INTERVIEWING THE CUSTOMER AND ASSISTING THEM WITH TROUBLESHOOTING THE UNIT. THE CUSTOMER CONFIRMED THEY COULD NOT HEAR AUDIBLE ALERTS AT THE PC'S THEY EXPECTED TO HEAR THEM (NURSES STATION CLIENTS 1 AND 2). THE RSE USED PHILIPS REMOTE SERVICES (PRS) TO LOG INTO THE UNIT AND DISCOVERED THE SYSTEM HAD BEEN RUNNING FOR 777 STRAIGHT DAYS WITHOUT A REBOOT. THE RSE RECOMMENDED THE CUSTOMER REBOOT THE SERVERS AND CLIENTS EVERY 30 DAYS AS RECOMMENDED THE GUIDE. THE RSE FOUND THAT MOST OF THE BEDS CONFIGURATIONS WERE SET TO ONLY ALERT AT CLIENT 2, WHICH THEY CANNOT GET THE APPLICATION TO RUN ON UNDER THE OBTV USER ACCOUNT THAT STAFF WAS LOGGING IN WITH. THE RSE HAD THE CUSTOMER CHANGE THE ACCOUNT THAT THEY WERE LOGGING INTO AND NOW CLIENT 2 IS UP AND RUNNING. THE RSE ALSO CHANGED THE CONFIGURATION TO SEND ALERTS TO THE 3 CLIENTS WHICH STAFF EXPECTED TO HEAR FROM. LASTLY, THE OTHER CLIENTS WERE NEW / REPLACEMENT CLIENTS AND REAL TIME ALERTING HAD NOT BEEN INSTALLED TO THEM, SO THIS INSTALL WAS ADDED TO THE BED ALERT CONFIGURATION. BASED ON THE INFORMATION AVAILABLE IN THE CASE AND THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED TO BE A CONFIGURATION ISSUE. THE REPORTED PROBLEM WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CUSTOMER WERE NOT HEARING THE PATIENT ALERTS WHERE THEY EXPECT TO HEAR THEM. 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
    744483 INTELLISPACE PERINATAL ADV SYS, INTEG ED INTELLISPACE PERINATAL ADV SYS, INTEG ED HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866132 00884838034532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown