BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VS4 VITAL SIGNS MONITOR

    MDR report key: 8043532 · Received November 6, 2018

    Report

    Report Number
    1218950-2018-08621
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Report Date
    October 9, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXN
    UDI-DI
    00884838087095
    PMA / PMN Number
    K120132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 A SPEAKER MALFUNCTION. IT IS NOT KNOWN AT THE TIME OF THIS REPORT WHETHER THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE COMPLAINT/EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT AND NO ADVERSE IMPACT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880895 VS4 VITAL SIGNS MONITOR PATIENT MONITOR DXN PHILIPS MEDICAL SYSTEMS 863283 00884838087095

    Patients

    Seq Age Sex Outcome Treatment
    1