BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VS2+ NBP/SPO2

    MDR report key: 3982624 · Received June 16, 2014

    Report

    Report Number
    1218950-2014-03412
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 19, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXN
    PMA / PMN Number
    K112652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN AUDIO FAILED AND SPEAKER MALFUNCTION INOP MESSAGE ON THE MONITOR. THE CUSTOMER STATED THAT THE DEVICE FAILED THE AUDIO ALARM TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353537 SURESIGNS VS2+ NBP/SPO2 DXN PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1