BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM8: MICROSTREAM CO2

    MDR report key: 4852493 · Received June 18, 2015

    Report

    Report Number
    1218950-2015-03129
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Report Date
    June 1, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SPEAKER WAS NOT WORKING. THERE WAS NO REPORT OF ANY ADVERSE IMPACT TO ANY USER OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396058 VM8: MICROSTREAM CO2 COMPACT PORTABLE PATIENT MONITORS MHX PHILIPS MEDICAL SYSTEMS 863066

    Patients

    Seq Age Sex Outcome Treatment
    1