BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 9205640 · Received October 17, 2019

    Report

    Report Number
    9610816-2019-00273
    Event Type
    Death
    Date Received
    October 17, 2019
    Date of Event
    October 9, 2019
    Report Date
    October 9, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE WITH THE CUSTOMER OVER THE PHONE. THE RCE CONFIRMED THAT THE CUSTOMER REQUIRED ONLY RETROSPECTIVE DATA FROM THE MONITOR AND THAT THE PRODUCT DID NOT MALFUNCTION. THE CUSTOMER HAS SUPPLIED PHILIPS NO ADDITIONAL INFORMATION. THE PHILIPS RCE CONFIRMED THAT NO PRODUCT MALFUNCTION OCCURRED; THE CUSTOMER WANTED ONLY RETROSPECTIVE DATA FROM THE MONITOR. THE RCE PROVIDED INSTRUCTIONS ON HOW TO RETRIEVE RETROSPECTIVE DATA FROM BOTH THE MONITOR AND THE CENTRAL MONITORING SYSTEM. THE DEVICE REMAINS AT THE CUSTOMER SITE, AND NO SUBSEQUENT CALLS HAVE BEEN LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION IS REQUIRED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS ATTEMPTING TO RETRIEVE RETROSPECTIVE DATA CONCERNING A PATIENT DEATH. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999632 MP70 INTELLIVUE PATIENT MONITOR PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1