BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP20 INTELLIVUE PATIENT MONITOR

    MDR report key: 7601071 · Received June 14, 2018

    Report

    Report Number
    9610816-2018-00149
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    April 18, 2018
    Report Date
    June 7, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PRODUCT MALFUNCTION. A REVIEW OF STRIPS OF THE EVENT PROVIDED BY THE CUSTOMER WAS PERFORMED BY A PHILIPS SOFTWARE DEVELOPMENT ENGINEER (SDE). THE SDE DETERMINED THAT THE ASYSTOLE WAS NOT CALLED, AS THE ST/AR ALGORITHM WAS MEASURING THE ARTIFACTS AS LARGER THAN 50% OF THE AVERAGE SIZE OF THE REGULARLY CLASSIFIED BEATS. BECAUSE OF THIS, THE MONITOR WOULD NOT FIND AN INTERVAL GREATER THAN THE ASYSTOLE LIMIT; THEREFORE, THERE WAS NO ALARMING. THE MONITOR WAS TESTED, AND IT WORKED PROPERLY; NO REPAIR WAS NEEDED. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ASYSTOLE ALARM WAS NOT GENERATED BY THE MONITOR ON (B)(6) 2018 AROUND 20:12. PHILIPS WAS NOT NOTIFIED TO THE PATIENT'S FINAL CONDITION, HOWEVER, THE CUSTOMER INDICATED THAT THE DOCTORS INTERVENED IN TIME, AND THAT THE PATIENT SUFFERED NO DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443663 MP20 INTELLIVUE PATIENT MONITOR COMPACT PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8001A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention