BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX C ST EFP

    MDR report key: 14238687 · Received April 28, 2022

    Report

    Report Number
    1218950-2022-00372
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 12, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ALARMS ON THEIR CENTRAL STATION WERE NOT EMITTING ANY AUDIBLE ALARMS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142569 PIC IX C ST EFP PIC IX C ST EFP MHX PHILIPS NORTH AMERICA LLC 453564867131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown