BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP60 INTELLIVUE PATIENT MONITOR

    MDR report key: 2243776 · Received July 29, 2011

    Report

    Report Number
    9610816-2011-00440
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 6, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE MONITOR DID NOT PRODUCE AN AUDIBLE ALARM. NO PT HARM WAS REPORTED. PT HARM/INJURY IS POSSIBLE SHOULD THE USER BE UNAWARE OF A CHANGE IN PT CONDITION FROM THE PRECONFIGURED PARAMETERS FOR THIS PT. PT IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR DID NOT PRODUCE AN AUDIBLE ALARM. NO PT HARM WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1