BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 1802742 · Received August 9, 2010

    Report

    Report Number
    9610816-2010-00295
    Event Type
    Death
    Date Received
    August 9, 2010
    Report Date
    July 21, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE MP30 ALARM DID NOT SOUND FOR A PT INCIDENT. BASED ON AVAILABLE INFORMATION, THE CUSTOMER DISCOVERED THAT THE ALARM SUSPEND SETTING WAS SET FOR 1 MINUTE SUSPEND (NOT INDEFINITE SUSPEND) AND FOUND THAT THE ECG PARAMETER ALARM WAS NOT TURNED OFF. 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 THE MP30 ALARM DID NOT SOUND FOR A PT INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death