BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX HARDWARE

    MDR report key: 11820522 · Received May 13, 2021

    Report

    Report Number
    1218950-2021-10531
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 16, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) TALKED TO THE CUSTOMER TO TROUBLESHOOT THE ISSUE. THE RSE CONFIRMED THE REPORTED ISSUE AND WAS INFORMED THAT THE UNIT WAS CONFIGURED FOR UNIT BASED POP UPS. THE CUSTOMER WAS TASKED WITH SETTING UP THEIR SIMULATOR TO TEST THE CAREGROUP POP UPS AND CALLING BACK TO RESOLVE THE ISSUE. THE CUSTOMER WAS UNREACHABLE AFTER THREE ATTEMPTS. THERE IS INSUFFICIENT INFORMATION TO RULE OUT A PRODUCT MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CAREGROUP POP UPS WERE NOT WORKING AS EXPECTED. 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 CARE GROUP POP UPS WERE NOT WORKING AS EXPECTED. 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
    716035 PIC IX HARDWARE PIC IX HARDWARE MHX PHILIPS NORTH AMERICA LLC 866424

    Patients

    Seq Age Sex Outcome Treatment
    1