BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3154 LARGE DATABASE SERVER REL L.0

    MDR report key: 2521373 · Received April 2, 2012

    Report

    Report Number
    1218950-2012-01035
    Event Type
    Death
    Date Received
    April 2, 2012
    Report Date
    March 14, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MHX
    PMA / PMN Number
    K101521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER IS REQUESTING ASSISTANCE IN OBTAINING RETROSPECTIVE DATA FOR A PT. THE PT EXPIRED. THERE WAS NO MALFUNCTION ALLEGED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT 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 IS REQUESTING ASSISTANCE IN OBTAINING RETROSPECTIVE DATA FOR A PT. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M3154 LARGE DATABASE SERVER REL L.0 MHX PHILIPS MEDICAL SYSTEMS-DUP M3154

    Patients

    Seq Age Sex Outcome Treatment
    1 Death