BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 2922626 · Received January 14, 2013

    Report

    Report Number
    1218950-2013-00156
    Event Type
    Death
    Date Received
    January 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 3, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS REQUESTED ASSISTANCE WITH ALARM LOGS FOLLOWING A PT DEATH. NO ALLEGATION OF DEVICE MALFUNCTION HAS BEEN MADE, HOWEVER A DELAY IN TREATMENT MAY HAVE OCCURRED. PHILIPS IN THE PROCESS OF OBTAINING ADDITIONAL INFO OCCURRING 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 HAS REQUESTED ASSISTANCE WITH ALARM LOGS FOLLOWING A PT DEATH. NO ALLEGATION OF DEVICE MALFUNCTION HAS BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20371 PHILIPS INFORMATION CENTER MHX, DRT MHX PHILIPS MEDICAL SYSTEMS M3150B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death