BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 3091442 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00351
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 22, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    993531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE UNIT AND FOUND SPO2 ERROR MESSAGES. CORRECTIONS INCLUDE REPLACEMENT OF THE SPO2 PCB BOARD. THE UNIT WAS TESTED TO FACTORY'S SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SPO2 MONITORING ON THE PASSPORT 2 MONITOR WORKED INTERMITTENTLY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187415 PASSPORT 2 MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1