BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM MONITOR

    MDR report key: 3091871 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00561
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    September 28, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    062098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE SPECTRUM MONITOR, WHICH MAY HAVE AFFECTED THE DISPLAY, POSSIBLY IMPACTING MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186449 SPECTRUM MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1