BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V SERIES MONITOR

    MDR report key: 2981041 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00049
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    August 27, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    102004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION INCLUDED REPLACEMENT OF V SERIES V-DOCK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE V SERIES MONITOR SHUTS DOWN AFTER 30 MINUTES OF USE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38525 V SERIES MONITOR NONE MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1