BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21630097 · Received March 18, 2025

    Report

    Report Number
    1218950-2025-000164
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 21, 2025
    Report Date
    March 27, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER BIOMED STATED THAT THEY WERE NOT AT THE INFORMATION CENTER IX AS THE DEVICE IS REMOTE FROM NETWORK CLOSET SO TROUBLE SHOOTING COULD NOT BE DONE AT THE TIME. THE REMOTE SERVICE ENGINEER (RSE) PROVIDED THE FOLLOWING TROUBLE SHOOTING INSTRUCTIONS TO HELP DIAGNOSE/RESOLVE THE ISSUE: 1. CONNECT A KNOWN GOOD SPEAKER DIRECTLY TO THE PC AUDIO CARD TO VALIDATE AUDIO. 2. IF NO AUDIO AND A SPARE PC IS AVAILABLE SWAP OUT THE CARD. 3. IF NO SPARE AUDIO KITS, THEN ORDER THE FOLLOWING PARTS NUMBERS. THE RSE PROVIDED TROUBLE SHOOTING INSTRUCTIONS TO HELP DIAGNOSE/RESOLVE THE ISSUE. THE CUSTOMER IS TAKING RESPONSIBILITY FOR SERVICING THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE CUSTOMER HAS BEEN NOTIFIED TO CONTACT PHILIPS FOR ANY FOLLOW UP.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT WAS INCORRECTLY SENT AS NOT COMPLETE, THE REPORT SHOULD HAVE BEEN A COMPLETE REPORT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PICIX WAS NOT EMITTING SOUND. 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
    884430 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown