BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V SERIES MONITOR

    MDR report key: 3102664 · Received May 1, 2013

    Report

    Report Number
    2221819-2013-01059
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    102004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE DID NOT HAVE FULL ACCESS TO EVALUATE DUE TO CURRENT USE OF THE DEVICE ON A PT AT THE TIME. SYSTEM'S ERROR LOGS WERE COLLECTED AND IS UNDER REVIEW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE V SERIES MONITOR SHUT DOWN, WHICH MAY HAVE RESULTED IN LOSS IN PRIMARY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190680 V SERIES MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1