BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 19219948 · Received May 1, 2024

    Report

    Report Number
    1218950-2024-00307
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 19, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND CONFIRMED THE REPORTED ISSUE SURVEILLANCE STATIONS DID NOT MAKE ANY SOUNDS. THE CUSTOMER SENT THE HARDWARE TO BENCH REPAIR FOR TROUBLESHOOTING AND REPAIR. DIAGNOSTIC/FUNCTIONAL TESTING WAS PERFORMED AT THE PHILIPS AUTHORIZED REPAIR FACILITY. THE BENCH REPAIR TECHNICIAN (BRT) REPRODUCED THE CUSTOMER ISSUE AND NOTICED THAT A CABLE WAS NOT CONNECTED TO THE MOTHERBOARD FROM THE POWER SUPPLY. AFTER RECONNECTING IT THE SOUND WORKED AGAIN. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS DUE TO A DISCONNECTED CABLE. THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. CORRECTED DATA: D4 UDI WAS CORRECTED FROM (B)(4). G5 510K WAS CORRECTED FROM K183387 TO K211900.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED NO SOUND IS COMING FROM THE CENTRAL STATION PIIC IX. THE BIOMED IDENTIFIED THAT THE SOUND CARD WAS PUSHED IN AND THE DEVICE WAS POSSIBLY DROPPED. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138242 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown