BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP40 INTELLIVUE PATIENT MONITOR

    MDR report key: 3982603 · Received June 16, 2014

    Report

    Report Number
    9610816-2014-00172
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 3, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ALARM IS NOT COMING OUT/SOUNDING OFF. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353555 MP40 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8003A

    Patients

    Seq Age Sex Outcome Treatment
    1