BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT V MONITOR

    MDR report key: 3231722 · Received July 12, 2013

    Report

    Report Number
    2221819-2013-01436
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 1, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    MHX
    PMA / PMN Number
    091834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REP EVALUATED THE UNIT AND IDENTIFIED AN ISSUE WITH THE SYSTEM'S CIRCUIT BOARD. A REPLACEMENT UNIT HAS BEEN PROVIDED FOR THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PASSPORT V MONITOR, WHICH MAY HAVE AFFECTED PT MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322519 PASSPORT V MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1