BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V SERIES MONITOR

    MDR report key: 3091568 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00409
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    December 6, 2012
    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
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPRESENTATIVES FOUND THE ECG ISSUES WERE SETTINGS RELATED AND RETURNED THE UNIT TO MINDRAY'S REPAIR CENTER FOR THE TOUCH SCREEN LOCK UP ISSUE. THE TOUCH SCREEN WAS REPLACED, SOFTWARE WAS UPGRADED, CALIBRATED AND SAFETY TESTED TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE V SERIES MONITOR TOUCH SCREEN LOCKED UP ISSUES WITH THE ECG, WHICH MAY HAVE RESULTED IN A POSSIBLE LOSS OF PRIMARY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187384 V SERIES MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1