BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VS4 VITAL SIGNS MONITOR

    MDR report key: 8063605 · Received November 13, 2018

    Report

    Report Number
    1218950-2018-08912
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Report Date
    October 16, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXN
    UDI-DI
    00884838028890
    PMA / PMN Number
    K120132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER DOES NOT WORK. THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE COMPLAINT/EVENT. THERE WAS NO ADVERSE EVENT TO A PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905227 VS4 VITAL SIGNS MONITOR PATIENT MONITOR DXN PHILIPS MEDICAL SYSTEMS 863283 00884838028890

    Patients

    Seq Age Sex Outcome Treatment
    1