BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 4090074 · Received August 18, 2014

    Report

    Report Number
    2221819-2014-00482
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    020550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAS BEEN RETURNED TO THE COMPANY'S REPAIR CENTER FOR FURTHER EVAL.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496255 PASSPORT 2 MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1