BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3154 LARGE DATABASE SERVER

    MDR report key: 1712817 · Received June 3, 2010

    Report

    Report Number
    1218950-2010-00841
    Event Type
    Death
    Date Received
    June 3, 2010
    Report Date
    May 25, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K062271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 06/02/2010, THE CUSTOMER INDICATED THAT A PATIENT DEATH OCCURRED IN (B) (6) 2009 IN THE ER. IT WAS STATED THAT THE MONITOR WAS NOT ALLEGED TO BE A FACTOR AND THAT THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. IN ABUNDANCE OF CAUTION, WE ARE REPORTING THIS INCIDENT. 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 PATIENT DEATH OCCURRED IN (B) (6) 2009; HOWEVER, IT WAS STATED THAT THE MONITOR WAS NOT ALLEGED TO BE A FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M3154 LARGE DATABASE SERVER MHX PHILIPS MEDICAL SYSTEMS M3154 (862177)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death