BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V SERIES MONITOR

    MDR report key: 4213141 · Received September 8, 2014

    Report

    Report Number
    2221819-2014-00540
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    102004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENTATION FROM THE EVENT WAS COLLECTED AND IS CURRENTLY UNDER REVIEW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PANORAMA CENTRAL STATION WITH V SERIES BEDSIDE MONITOR FALSELY IDENTIFIED VENTRICULAR TACHYCARDIA ON A PT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550968 V SERIES MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1