BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 22565651 · Received July 22, 2025

    Report

    Report Number
    9610816-2025-000650
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    July 15, 2025
    Report Date
    July 22, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838122772
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REMOTE CLINICAL SPECIALIST (RCS) REVIEWED THE CLINICAL AUDIT TRAIL WITH THE BIOMED TECHNICIAN. THE RCS CONFIRMED THAT THE MONITOR GENERATED PAUSE YELLOW ALARM, THE PAUSE ALARM WAS ACKNOWLEDGED AND THE USER ANNOTATED/SAVED STRIP. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE ICU MONITOR (BED ICU8) DID NOT GENERATE A YELLOW PAUSE ALARM. 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
    1574359 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX 00884838122772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown