BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP50 INTELLIVUE PT MONITOR

    MDR report key: 2212938 · Received August 4, 2011

    Report

    Report Number
    9610816-2011-00464
    Event Type
    Injury
    Date Received
    August 4, 2011
    Report Date
    July 27, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE REPORTED DESCRIPTION NOTES THAT THE PT HAD A SERIOUS EVENT REQUIRING DEFIBRILLATION. THE CUSTOMER WAS LOOKING FOR INFORMATION ON CAPTURING RETROSPECTIVE DATA. THERE WAS NO REPORT OF A PT MONITOR MALFUNCTION. HOWEVER, BECAUSE THERE IS AN INDICATION THAT A LIFE THREATENING SITUATION OCCURRED, PHILIPS WILL REPORT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO 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 REPORTED DESCRIPTION NOTES THAT THE PT HAD A SERIOUS EVENT REQUIRING DEFIBRILLATION. THE CUSTOMER WAS LOOKING FOR INFORMATION ON CAPTURING RETROSPECTIVE DATA. THERE WAS NO REPORT OF A PT MONITOR MALFUNCTION. HOWEVER, BECAUSE THERE IS AN INDICATION THAT A LIFE THREATENING SITUATION OCCURRED, PHILIPS WILL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1