BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSIE III MONITOR

    MDR report key: 3091843 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-01003
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MWI
    PMA / PMN Number
    051897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPRESENTATIVE REPLACED THE TEMPERATURE MODULE. UNIT WAS CALIBRATED AND SAFETY TESTED TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ROSIE III MONITOR HAD NO TEMPERATURE READINGS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187059 ROSIE III MONITOR PATIENT MONITOR MWI MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1