BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX C ST EFP

    MDR report key: 15542283 · Received October 5, 2022

    Report

    Report Number
    1218950-2022-00902
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 13, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY CANNOT HEAR THE ALARM FROM THE UNIT. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PIC IX C ST EFP INDICATING THAT THE CUSTOMER COULD NOT HEAR THE ALARM. THERE WAS NO PATIENT OR USER HARM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO ASSIST THE CUSTOMER. THE FSE FOUND THAT THE NETWORK CABLE WAS PLUGGED INTO THE WRONG PORT AND THA MOVED THE NETWORK CABLE TO A DIFFERENT PORT. AFTER MOVING THE CABLE, THE SOUND WAS RECEIVED REMOTELY TO THE CENTRAL STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505719 PIC IX C ST EFP PIC IX C ST EFP MHX PHILIPS NORTH AMERICA LLC 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown