BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS DATABASE SERVER

    MDR report key: 1659048 · Received April 12, 2010

    Report

    Report Number
    1218950-2010-00490
    Event Type
    Death
    Date Received
    April 12, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 6, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K06227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT A PT DEATH HAD OCCURRED AND THEY WERE SEEKING INFO REGARDING ALARM SETTINGS ON THE MONITOR IN USE AT THE TIME OF THE INCIDENT. AS OF 4/12/10, THE AVAILABLE INFO DOES NOT SUPPORT THAT THE DEVICE WAS A FACTOR AND NO ALLEGATION THAT THE DEVICE WAS A FACTOR WAS MADE BY THE CUSTOMER. NO ALLEGATION OF ANY MALFUNCTION WAS MADE. 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. (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT DEATH HAD OCCURRED; HOWEVER, THEY WERE SEEKING INFO REGARDING ALARM SETTINGS ON THE MONITOR IN USE AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS DATABASE SERVER MHX PHILIPS MEDICAL SYSTEMS M3154B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death