BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V SERIES MONITOR

    MDR report key: 3091763 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00177
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 11, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    K102004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPRESENTATIVES ATTEMPTED TO EVALUATE THE UNIT BUT CUSTOMER DID NOT MAKE THE UNIT AVAILABLE. THERE HAVE BEEN NO ADDITIONAL REPORTS OF THE ISSUE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO HEART RATE NUMERICS WERE DISPLAYED ON THE V SERIES MONITOR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187242 V SERIES MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1