BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN, INC.

    MDR report key: 6307027 · Received February 7, 2017

    Report

    Report Number
    6307027
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    March 2, 2016
    Report Date
    December 28, 2016
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROPAQ MONITOR SHUT OFF AFTER PLACING IT ON PATIENT. ERROR MESSAGE 2-008-0000 UNABLE TO MONITOR PATIENT UNTIL LOADED INTO AIRCRAFT AND PLACED ON DIFFERENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89837 WELCH ALLYN, INC. MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI WELCH ALLYN, INC. 901061

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR