BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT V MONITOR

    MDR report key: 4190162 · Received October 17, 2014

    Report

    Report Number
    2221819-2014-00810
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    091834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ISSUE CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PASSPORT V MONITOR FELL OFF FROM THE ROLLING STAND AND THE NURSE CAUGHT IT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662332 PASSPORT V MONITOR PT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1