BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 4122236 · Received September 18, 2014

    Report

    Report Number
    2221819-2014-00547
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 30, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    K020550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF THE UNIT'S CPU BOARD COMPONENTS. UNIT WAS CALIBRATED AND TESTED TO FACTORY'S SPECS.

    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
    578913 PASSPORT 2 MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1