BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP60 INTELLIVUE PATIENT MONITOR

    MDR report key: 3170937 · Received June 6, 2013

    Report

    Report Number
    9610816-2013-00122
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 14, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ABP LOW ALARM LIMIT ON THEIR INTELLIVUE MP60 MONITOR WAS SET TO 75 MMHG AND THAT THE MONITOR DID NOT GIVE AN ALARM SOUND WHEN THE ABP FELL TO 40 MMHG. THERE WAS NO DEATH OR SERIOUS INJURY AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252004 MP60 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8005A

    Patients

    Seq Age Sex Outcome Treatment
    1