BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2

    MDR report key: 2981029 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00033
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    November 7, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    DSI
    PMA / PMN Number
    993531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENTS OF THE MAIN CPU BOARD AND SPO2 BOARD. THE UNIT WAS TESTED TO FACTORY'S SPECS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PASSPORT 2 MONITOR HAD AN ABRUPT SHUT DOWN AND A NON FUNCTIONAL SPO2 BOARD. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38302 PASSPORT 2 NONE DSI MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1