BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 3760959 · Received April 10, 2014

    Report

    Report Number
    9610816-2014-00095
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BLOCKS WERE APPEARING ON THE WAVE FORM, AND THE SYSTEM DID NOT ALARM. THE NURSE STATED SHE ENTERED THE PATIENT ROOM AND FOUND THE PATIENT UNRESPONSIVE; THE PATIENT HAD TO BE TREATED WITH BETA BLOCKER AND OTHER MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216365 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1