BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON ACT MONITOR

    MDR report key: 787773 · Received June 23, 2006

    Report

    Report Number
    MW1041202
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 22, 2006
    Report Date
    June 15, 2006
    Manufacturer
    ITC
    Product Code
    KQG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 4001 MODEL HEMOCHRON ACT MONITOR DID NOT TURN PROPERLY; INACCURATE READINGS. PROTAMINE REQUIRED TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ACT MONITOR * KQG ITC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR