BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP50 INTELLIVUE PATIENT MONITOR

    MDR report key: 3033339 · Received March 1, 2013

    Report

    Report Number
    9610816-2013-00047
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Report Date
    January 31, 2013
    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): THE CUSTOMER REPORTED THAT VITALS WENT BELOW SET LIMITS AND THE MONITOR DID NOT ALARM. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT 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 VITALS WENT BELOW SET LIMITS AND THE MONITOR DID NOT HARM. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90301 MP50 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8004A

    Patients

    Seq Age Sex Outcome Treatment
    1