BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE MP5

    MDR report key: 2861673 · Received December 4, 2012

    Report

    Report Number
    9610816-2012-00491
    Event Type
    Injury
    Date Received
    December 4, 2012
    Report Date
    November 27, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K091395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATES THAT THE CHILD DESATURATED TO 59% AND THAT THE MP5 MONITOR DID NOT ALARM. AS THE DOCTOR PASSED BY THE PATIENT ROOM, THE PATIENT WAS FOUND WITH BLUE SKIN. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER THE DEVICE CONTRIBUTED TO THIS INJURY. PHILIPS IS IN THE PROCESS OR OBTAINING ADDITIONAL INFORMATION 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 STATES THAT THE CHILD DESATURATED TO 59% AND THAT THE MP5 MONITOR DID NOT ALARM. AS THE DOCTOR PASSED BY THE PATIENT ROOM, THE PATIENT WAS FOUND WITH BLUE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MP5 MHX PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1