BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MP2

    MDR report key: 5093617 · Received September 22, 2015

    Report

    Report Number
    9610816-2015-00196
    Event Type
    Death
    Date Received
    September 22, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 10, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) AT 2:00 TO 2:30AM CUSTOMER SAID THAT THERE WAS NO ALARMING FROM MONITOR. THE CPR WAS NOT SUCCESSFUL AND THE PATIENT IS DECEASED. A FIELD SERVICE ENGINEER (FSE) WAS ONSITE AND PROVIDED SCREENSHOTS FROM THE ALARM OVERVIEW, DEVICE LIST, CONFIGURATION LIST, DEVICE REPORT, STRIPES, STATUS LOG, EXPORT LOGS AND THE INVESTIGATION RESULTS. HE CONFIRMED THAT THE CUSTOMER SWITCHED THE ECG/ARR. ALARM ON (B)(6)AT 16:15:33 OFF. HE PROVIDED THE CUSTOMER WITH HIS FINDINGS. A CALL WITH THE RESPONSIBLE FSE CONFIRMED THAT ONLY THE ECG PARAMETER WAS ATTACHED TO THE PATIENT. THE REPORTED COMPLAINT IS NOT RELATED TO A PRODUCT MALFUNCTION. THE FSE CONFIRMED THAT THE CUSTOMER SWITCHED OFF THE ECG/ARR. ALARM. HE PROVIDED THE CUSTOMER WITH HIS FINDINGS. THE CUSTOMER SWITCHED OFF THE ECG/ARR. ALARM WHICH WAS EXPLAINED BY THE FSE. ALSO A WRITTEN BIU RESPONSE WAS SENT TO THE CUSTOMER. THE COMPLAINT IS CONSIDERED AS USER RELATED AND NO MALFUNCTION OF THE DEVICE. THERE IS NO INDICATION THAT THIS FAILURE COULD BE DIFFICULT TO DETECT. ADDITIONALLY, THE AVAILABLE INFORMATION FROM THIS REPORT DOES NOT SUPPORT THAT THIS FAILURE REPRESENTS A SYSTEMIC, DESIGN, OR LABELING PROBLEM. THIS COMPLAINT DOES NOT REPRESENT A PRODUCT/PART FAILURE, AND THEREFORE THIS CASE WILL BE EXCLUDED FROM PERIODIC MONITORING. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. PHILIPS MEDICAL SYSTEMS (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) FROM 2:00 TO 2:30AM THERE WAS NO ALARMING FROM MONITOR. THE PATIENT HAD BEEN FOUND LATER THAT NIGHT BETWEEN 5 & 6 AM. THE CPR WAS NOT SUCCESSFUL AND THE PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626568 INTELLIVUE MP2 PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8102A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death