BEUDAMED
    FDA Adverse Event Death Summary report: N

    VM8

    MDR report key: 1667313 · Received April 21, 2010

    Report

    Report Number
    1218950-2010-00545
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    March 25, 2010
    Report Date
    April 20, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT AN SPO2 VALUE OF 68% WAS DISPLAYED ON THE MONITOR FIFTEEN MINUTES AFTER A PT DEATH. THE AVAILABLE INFORMATION DOES NOT SUPPORT THAT THERE WAS ANY MALFUNCTION OR HEALTH RISK. THERE IS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED THE PT DEATH. 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. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN SPO2 VALUE OF 68% WAS DISPLAYED ON THE MONITOR FIFTEEN MINUTES AFTER A PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VM8 MHX PHILIPS MEDICAL SYSTEMS 863068

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death