BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 17143866 · Received June 16, 2023

    Report

    Report Number
    1218950-2023-00423
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 23, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838086715
    PMA / PMN Number
    K153702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT THAT THE PIC IX IS NOT SENDING RED ALARMS TO THE CENTRAL STATION, ALTHOUGH ALARMS ARE SHOWING AND ALARMING AT THE BEDSIDE. IT IS THE ONLY BED IN THAT AREA EXPERIENCING THIS ISSUE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. THE BIOMED PERFORMED TROUBLESHOOTING AND THE NURSE EXPLAINED THE RED ALARM IS VISIBLE AT THE CENTRAL STATION BUT IS NOT PRODUCING SOUND. THE BIOMED EXAMINED THE EXTERNAL SPEAKER AND FOUND THE CONNECTION WAS LOOSE. THEY RECONNECTED THE SPEAKER. A TEST WAS CONDUCTED BY CREATING A RED ALARM AND CONFIRMED THAT SOUND CAN BE HEARD. THE ISSUE WAS RESOLVED BY RECONNECTING THE EXTERNAL SPEAKER, THE DEVICE REMAINS IN USE AT THE CUSTOMER'S SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551584 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838086715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown