BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V SERIES MONITOR

    MDR report key: 3102637 · Received May 1, 2013

    Report

    Report Number
    2221819-2013-01045
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    102004
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S IN-HOUSE TECHNICIAN EVALUATED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE V SERIES MONITOR WERE "MISSING LETHAL ALARMS", WHICH MAY HAVE AFFECTED PT MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190156 V SERIES MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1