BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIIC IX HARDWARE

    MDR report key: 7185397 · Received January 12, 2018

    Report

    Report Number
    1218950-2018-00337
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Report Date
    December 29, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD BEEN UPGRADED TO PIIC IX A MONTH AGO AND THEY WERE NOT RECEIVING AUDIO BECAUSE THE SYSTEM HAD NO EXTERNAL SPEAKER. THERE WAS NO PATIENT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29801 PIIC IX HARDWARE CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866424

    Patients

    Seq Age Sex Outcome Treatment
    1