BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT V MONITOR

    MDR report key: 4090114 · Received August 18, 2014

    Report

    Report Number
    2221819-2014-00501
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF THE SPO2 SENSOR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PASSPORT 2 MONITOR, WHICH MAY HAVE AFFECTED SPO2 MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496310 PASSPORT V MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1