BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2973615 · Received February 12, 2013

    Report

    Report Number
    9610816-2013-00033
    Event Type
    Death
    Date Received
    February 12, 2013
    Report Date
    January 16, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE DEATH WAS RELATED TO A USER ERROR (SWITCHING TO COMFORT SCREEN), THIS COMPLAINT WAS DEEMED REPORTABLE SINCE THE MONITOR CONTRIBUTED TO THE EVENT AS A RESULT OF USER ERROR. A FULL INVESTIGATION WILL BE DONE. PRODUCT LABELING WARNS THE USER THAT THE MOST RELIABLE METHOD OF PT MONITORING COMBINES CLOSE PERSONAL SURVEILLANCE WITH CORRECT OPERATION OF MONITORING EQUIPMENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 REPORTED THAT A PT EXPIRED AND THE MONITOR DID NOT GENERATE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62331 MP70 INTELLIVUE PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death