BEUDAMED
    FDA Adverse Event Death Summary report: N

    VS4 VITAL SIGNS MONITOR

    MDR report key: 7996003 · Received October 23, 2018

    Report

    Report Number
    1218950-2018-08317
    Event Type
    Death
    Date Received
    October 23, 2018
    Report Date
    October 16, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXN
    PMA / PMN Number
    K120132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. IT IS UNKNOWN AT THE TIME OF THIS REPORT IF THE DEVICE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    CUSTOMER CARE RESOLUTION CENTER (CCSC) PROVIDED TROUBLESHOOTING ASSISTANCE. SAFETY AND FUNCTIONAL TESTS WERE DONE AND THE DEVICE PASSED ALL TESTING. A COMPREHENSIVE LOG ANALYSIS ALSO CONFIRMED NO PRODUCT MALFUNCTION. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE DEVICE BATTERY DURING TESTING ,BUT NOT FOR THE PURPOSE OF ADDRESSING THE REPORTED ISSUE. THIS COMPLAINT HAS BEEN EVALUATED AND DOES NOT ALLEGE A DEATH, SERIOUS INJURY, OR SAFETY ISSUE. THE DEPUTY WARD MANAGER AT THE CUSTOMER SIDE, CONFIRMED ON (B)(6)-2018 THAT THE DEATH OF THE PATIENT WAS NOT RELATED TO THE BEHAVIOR OF THE DEVICE.THE DEVICE REMAINS AT THE CUSTOMER SITE .THERE HAVE BEEN NO ADDITIONAL CALLS FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FOLLOWING VALUES WERE MEASURED IN A DECEASED PATIENT: 14.10.2018/15:35:38 PULSE 77, SPO2 89%, RR -/-, TEMP. 34.4.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MEASURED READINGS WERE OBTAINED FROM A DECEASED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837167 VS4 VITAL SIGNS MONITOR PATIENT MONITOR DXN PHILIPS MEDICAL SYSTEMS 863283

    Patients

    Seq Age Sex Outcome Treatment
    1