BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 22082497 · Received May 25, 2025

    Report

    Report Number
    1218950-2025-000316
    Event Type
    Malfunction
    Date Received
    May 25, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 25, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SUPPORT ENGINEER (FSE) WENT TO THE CUSTOMER'S SITE. IT WAS ESTABLISHED THE AUDIO WAS ROUTED TO THE WRONG CHANNEL/DEVICE. AFTER ROUTING THE AUDIO OUTPUT TO THE CORRECT CHANNEL/DEVICE THE ISSUE WAS RESOLVED. THE DEVICE WAS OPERATIONAL AFTER THE AUDIO WAS RECONNECTED CORRECTLY. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. REPORTING INSTITUTION PHONE NUMBER: (B)(6). REPORTER PHONE NUMBER: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THE ACOUSTIC ALARM OF THE PATIENT INFORMATION CENTER IX IS NOT WORKING. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330171 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown