BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 20429046 · Received October 11, 2024

    Report

    Report Number
    1218950-2024-00731
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 16, 2024
    Report Date
    November 21, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838121782
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS REPORTED UNDER INCORRECT REGISTRATION NUMBER, PLEASE REFER TO MFR REPORT NUMBER 9610816-2024-000890 FOR FURTHER INFORMATION REGARDING THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ALARMS FROM THE BEDSIDE WOULD NOT AUDIBLY ALERT AT NURSE STATION. THE PC WAS REBOOTED AND THE ALARM SOUNDS STARTED WORKING. 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
    312844 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838121782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown