BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP30 INTELLIVUE PT MONITOR

    MDR report key: 2243929 · Received September 6, 2011

    Report

    Report Number
    9610816-2011-00520
    Event Type
    Death
    Date Received
    September 6, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 26, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DESCRIPTION NOTES THAT A PT DEATH OCCURRED WHILE PT MONITORING WAS OCCURRING. THE CUSTOMER DOEST NOT ALLEGE THAT THE DEATH WAS RELATED TO A PRODUCT MALFUNCTION OF THE BEDSIDE MONITOR. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 REPORTED DESCRIPTION NOTES THAT A PT DEATH OCCURRED WHILE PT MONITORING WAS OCCURRING. THE CUSTOMER DOES NOT ALLEGE THAT THE DEATH WAS RELATED TO A PRODUCT MALFUNCTION OF THE BEDSIDE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP30 INTELLIVUE PT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8002A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death