BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 1873525 · Received October 14, 2010

    Report

    Report Number
    9610816-2010-00538
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Report Date
    September 22, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A NON INVASIVE BLOOD PRESSURE WAS INCORRECTLY CALCULATED BY AN X2 MONITOR BECAUSE THE CLINICIAN CHOSE THE WRONG PATIENT CATEGORY SETTING. THE CLINICIAN GAVE INCORRECT MEDICATION BASED ON THE INCORRECT BP VALUE. NO PATIENT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 NON INVASIVE BLOOD PRESSURE WAS INCORRECTLY CALCULATED BY AN X2 MONITOR. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1