BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 3091195 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00754
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    020550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE SYS. REPLACED MEMORY CHIP, AND UPGRADED TO SYSTEM SOFTWARE. RESEATED CABLES. CALIBRATED AND SAFELY TESTED UNIT TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PASSPORT 2 MONITOR'S PORT WAS NOT RECOGNIZING THE GAS MODULE WHICH MAY HAVE RESULTED IN LOSS OF GAS MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187322 PASSPORT 2 MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1