BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 8443939 · Received March 21, 2019

    Report

    Report Number
    MW5085069
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    March 8, 2019
    Report Date
    March 19, 2019
    Manufacturer
    MERGE HEALTHCARE INC.
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MARGE HEMO DEVICE WAS READING PT'S PULSE / HEART RATE AS "0". PT HAD TO BE PLACED ON THE DEFIBRILLATOR MONITOR TO CAPTURE THE CORRECT PT'S HEART RATES. UDI ((B)(4), VERSION: 10.0.4.4395.DC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234832 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMER DQK MERGE HEALTHCARE INC. VERSION 10.0.4.4395.DC

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other