BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VS2+ NBP/SPO2/WIRELESS

    MDR report key: 7926737 · Received October 2, 2018

    Report

    Report Number
    1218950-2018-07796
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Report Date
    September 5, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXN
    PMA / PMN Number
    K112652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER NOT PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. THE CUSTOMER REPORTED THAT THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO ADVERSE EVENT TO A PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767192 SURESIGNS VS2+ NBP/SPO2/WIRELESS PATIENT MONITOR DXN PHILIPS MEDICAL SYSTEMS 863279

    Patients

    Seq Age Sex Outcome Treatment
    1