BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 3832018 · Received March 7, 2014

    Report

    Report Number
    2221819-2014-00082
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 25, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    020550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE SYSTEM. CORRECTION INCLUDES REPLACEMENT OF THE CPU BOARD AND CO2 MODULE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PASSPORT 2 MONITOR SHUT DOWN, WHICH MAY HAVE AFFECTED PT MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138785 PASSPORT 2 MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1