BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFORMATION CENTER NETWORK DATABASE

    MDR report key: 2070273 · Received April 19, 2011

    Report

    Report Number
    1218950-2011-01048
    Event Type
    Death
    Date Received
    April 19, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K041741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT DURING DELIVERY, A PT EXPERIENCED SEVERAL DESATURATIONS AND HEART ATTACKS WHILE BEING MONITORED USING A PHILIPS DEVICE. THERE IS NO INDICATION OF ANY PROBLEM WITH REAL-TIME MONITORING OR ALARM ANNUNCIATION FUNCTIONS. ALTHOUGH A PT DIED, THE AVAILABLE INFO DOES NOT SUPPORT THAT THE USE OF THE MONITOR WAS A FACTOR IN THE DEATH. THE CUSTOMER NEEDS HELP IN RECOVERING PT DATA FOR RETROSPECTIVE ANALYSIS. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L 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 DURING DELIVERY, A PT EXPERIENCED SEVERAL DESATURATIONS AND HEART ATTACKS WHILE BEING MONITORED USING A PHILIPS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFORMATION CENTER NETWORK DATABASE MHX DRT MHX PHILIPS HEALTHCARE 862124 (M3150B)

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death