BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPACT MONITOR DISPLAY

    MDR report key: 1747707 · Received June 30, 2010

    Report

    Report Number
    9610816-2010-00226
    Event Type
    Death
    Date Received
    June 30, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 25, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K001664
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED; HOWEVER, THE CUSTOMER STATED THAT THE DEVICE WAS NOT CONSIDERED TO BE A CONTRIBUTING FACTOR IN THE INCIDENT. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION AND THE CUSTOMER REQUESTED ASSISTANCE OBTAINING DATA FOR RETROSPECTIVE REVIEW. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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; HOWEVER, THE CUSTOMER STATED THAT THE DEVICE WAS NOT CONSIDERED TO BE A CONTRIBUTING FACTOR IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT MONITOR DISPLAY MHX, DRT MHX PHILIPS MEDICAL SYSTEMS M3046A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death