BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VS2+ NBP/SPO2

    MDR report key: 4812697 · Received June 2, 2015

    Report

    Report Number
    1218950-2015-02955
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 8, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXN
    PMA / PMN Number
    K112652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    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 THAT THE SPEAKER WAS MALFUNCTIONING. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355056 SURESIGNS VS2+ NBP/SPO2 PATIENT MONITOR DXN PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1