BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VSI - NBP/SPO2

    MDR report key: 8134448 · Received December 5, 2018

    Report

    Report Number
    1218950-2018-09495
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Report Date
    October 29, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXN
    PMA / PMN Number
    K112652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PATIENT MONITOR SURE SIGNS VSI - NBP/SPO2 HAS AN AUDIO PROBLEM. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972409 SURESIGNS VSI - NBP/SPO2 PATIENT MONITOR DXN PHILIPS MEDICAL SYSTEMS 863276

    Patients

    Seq Age Sex Outcome Treatment
    1