BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT V MONITOR

    MDR report key: 3131191 · Received May 23, 2013

    Report

    Report Number
    2221819-2013-01132
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    October 5, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    091834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT AND REPLACED THE SPO2 CABLE AND SENSOR. CUSTOMER ORDERED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PASSPORT V MONITOR, WHICH MAY HAVE RESULTED IN A LOSS OF SPO2 MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228466 PASSPORT V MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1