BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE MUTLI MEASUREMENT SERVER (MMS)

    MDR report key: 5637518 · Received May 6, 2016

    Report

    Report Number
    9610816-2016-00128
    Event Type
    Injury
    Date Received
    May 6, 2016
    Date of Event
    April 21, 2016
    Report Date
    April 22, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. NO ADDITIONAL TREATMENT WAS WARRANTED AS A RESULT OF THE PATIENT BEING GIVEN BLOOD PRESSURE MEDICATION AND THE PATIENT IS FINE. THE FSE INITIALLY SWAPPED OUT THE INTELLIVUE MULTI MEASUREMENT SERVER AS A PRECAUTION. DURING THE ENSUING INVESTIGATION, THE FSE FOUND THE AFFECTED DEVICE TO BE OPERATING AS SPECIFIED AND EXPECTED AND THE CALIBRATION OF THE MEASUREMENT SERVER TO BE CORRECT. THE CUSTOMER¿S INTELLIVUE MULTI MEASUREMENT SERVER (MMS) SOFTWARE REVISION HAS THE NEWER INTERNATIONAL STANDARD ISO 81060-2. TO MEET THE REQUIREMENTS FOR MEAN ERRORS AT THE CHANGED DISTRIBUTION REQUIREMENTS OF ISO 81060-2, THE COMPUTATION OF THE NBP READINGS FOR THE AUSCULTATORY REFERENCE METHOD WAS CHANGED WITH SOFTWARE RELEASE K.2. THE CUSTOMER¿S MMS DEVICE IS AT RELEASE L.01.05 AND THEREFORE HAS THE NEWER STANDARD. THIS CHANGE LEADS ON AVERAGE TO SLIGHTLY HIGHER DIASTOLIC AND MEAN ARTERIAL PRESSURE READINGS COMPARED TO FORMER RELEASES. THE CUSTOMER WAS INFORMED OF THIS CHANGE. A PHILIPS RESEARCH AND DEVELOPMENT (R&D) ENGINEER REVIEWED THE ISSUES AND STATED THAT THE CHANGES IN THE NBP MEASUREMENTS BASED ON THE NEW INTERNATIONAL STANDARD ARE MINIMAL. THE MEDIAN DEVIATION IS 5 MMHG, WHICH IS CLINICALLY NOT SIGNIFICANT (THE NBP STANDARDS FOR THE CLINICAL ACCURACY OF NBP MEASUREMENTS ALLOW +/- 5 MMHG). BOTH THE OLD STANDARD ANSI/AAMI SP10 AS WELL AS THE NEW ISO 81060-2 FULFILL THIS REQUIREMENT. EVEN IF A HOSPITAL HAS VERY INFLEXIBLE THRESHOLDS FOR ADMINISTERING BLOOD PRESSURE MEDICATION, IT IS NOT TO BE EXPECTED THAT ANY MEDICATION WOULD CAUSE HARM TO THE PATIENT AS THE ELEVATED BLOOD PRESSURE WOULD AT BEST BE BORDERLINE. EVEN WITH THE NEW STANDARD, THE ACCURACY OF THE NBP MEASUREMENTS IS WITHIN THE REQUIRED LIMITS, THEREFORE THIS CHANGE DOES NOT RESULT IN A POTENTIAL SAFETY ISSUE. IT HAS BEEN ESTABLISHED THAT THERE WAS NO PRODUCT MALFUNCTION. THIS ISSUE WAS CAUSED BY THE CUSTOMER NOT BEING AWARE OF THE NEW INTERNATIONAL STANDARD ISO 81060-2, WHICH RESULTS IN SLIGHTLY HIGHER DIASTOLIC AND MEAN ARTERIAL NON-INVASIVE BLOOD PRESSURE READINGS. THERE WAS NO PRODUCT MALFUNCTION. THE CUSTOMER WAS INFORMED OF THE CHANGES IN THE NBP MEASUREMENTS ASSOCIATED WITH THE NEW INTERNATIONAL STANDARD. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BLOOD PRESSURE READINGS. THE PATIENT WAS GIVEN BLOOD PRESSURE MEDICATION BASED ON THE READING. NO FURTHER INFORMATION REGARDING THE PATIENT CONDITION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293316 INTELLIVUE MUTLI MEASUREMENT SERVER (MMS) COMPACT PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M3001A

    Patients

    Seq Age Sex Outcome Treatment
    1