BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VS3; NBP, SPO2, TEMP

    MDR report key: 3891929 · Received February 10, 2014

    Report

    Report Number
    1218950-2014-00604
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Report Date
    January 14, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 THE MONITOR WAS FREEZING UP INTERMITTENTLY WHILE IN USE. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88769 VS3; NBP, SPO2, TEMP MHX PHILIPS MEDICAL SYSTEMS 863073

    Patients

    Seq Age Sex Outcome Treatment
    1