BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX C ST EFP

    MDR report key: 12143213 · Received July 9, 2021

    Report

    Report Number
    1218950-2021-10709
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 21, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR PATIENT INFORMATION CENTER WAS NOT EMITTING ANY AUDIO FOR ALARM EVENTS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR PATIENT INFORMATION CENTER WAS NOT EMITTING ANY AUDIO FOR ALARM EVENTS. 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
    1038049 PIC IX C ST EFP PIC IX C ST EFP MHX PHILIPS NORTH AMERICA LLC 453564867131

    Patients

    Seq Age Sex Outcome Treatment
    1