BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE MX800 PATIENT MONITOR

    MDR report key: 8897310 · Received August 15, 2019

    Report

    Report Number
    9610816-2019-00214
    Event Type
    Injury
    Date Received
    August 15, 2019
    Date of Event
    July 31, 2019
    Report Date
    July 31, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE INTELLIVUE MX800 PATIENT MONITOR SHOWED HIGH NON INVASIVE BLOOD PRESSURE READINGS (NIBP). FIRST READING WAS 240/96, THE SECOND READING WAS 212/193. A PATIENT HAD STROKE SYMPTOMS AND WAS ELIGIBLE FOR THE "BLOCKAGE BUSTER" MEDICATION, TPA. THERE ARE STRICT EXCLUSIONARY PARAMETERS FOR ADMINISTERING THIS MEDICATION, AND SOME OF THOSE INCLUDE BLOOD PRESSURE MEASUREMENTS. THE UPPER BLOOD PRESSURE NUMBER MUST BE UNDER 180MMHG. THE PHILLIPS MEASUREMENTS WOULD HAVE EXCLUDED THE PATIENT FROM RECEIVING THE MEDICATION. THE PATIENTS NIBP WAS THAN CHECKED MANUALLY BY NURSING STAFF, THE FIRST MANUAL READING WAS 178/172 AND THE SECOND WAS 155/75. AFTER THE MEDICATION WAS ADMINISTERED TO THE PATIENT, THE CLINICAL STAFF NOTICED AN IMMEDIATE IMPROVEMENT IN THE PATIENT. THE CUSTOMER REFUSED SERVICE AND AN EVALUATION OF THE INVOLVED DEVICE WAS NOT POSSIBLE. NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER AND THE EXACT CAUSE FOR THE REPORTED ISSUE REMAINS UNKNOWN. THE DEVICE REMAINS AT THE CUSTOMER SITE. DUE TO THE LACK OF AVAILABLE INFORMATION, PHILIPS CANNOT RULE OUT A MALFUNCTION OF THE DEVICE. THE AVAILABLE INFORMATION FROM THIS REPORT DOES NOT SUPPORT THAT THIS FAILURE REPRESENTS A SYSTEMIC, DESIGN, OR LABELING PROBLEM. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS NON INVASIVE BLOOD PRESSURE READINGS (NIBP) WHICH WOULD HAVE EXCLUDED THE STROKE PATIENT FROM RECEIVING "BLOCKAGE BUSTER" MEDICATION. PATIENT HAD A CARDIAC ARREST AND WAS TREATED WITH MULTIPLE LIFE SUSTAINING MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690559 INTELLIVUE MX800 PATIENT MONITOR INTELLIVUE MX800 PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 865240 (MX800)

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention