BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VS2+ NBP/SPO2/WIRELESS

    MDR report key: 12371132 · Received August 26, 2021

    Report

    Report Number
    1218950-2021-10852
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 30, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    UDI-DI
    00884838028401
    PMA / PMN Number
    K111114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER FAULT. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.THE SURESIGNS VS2+ NBP/SPO2/WIRELESS (MODEL NUMBER 863355) IS SUBSTANTIALLY SIMILAR TO THE SURESIGNS VS2+ NBP/SPO2/WIRELESS (MODEL NUMBER 863279) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL NUMBER 863279 (CFN/FEI # (B)(4); 510K K111114).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266981 SURESIGNS VS2+ NBP/SPO2/WIRELESS SURESIGNS VS2+ NBP/SPO2/WIRELESS MHX PHILIPS NORTH AMERICA LLC 863279 00884838028401

    Patients

    Seq Age Sex Outcome Treatment
    1