BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM MONITOR

    MDR report key: 3091455 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00374
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 29, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE UNIT AND FOUND THAT THE UNIT FAILED CO2 CALIBRATION. CORRECTIONS INCLUDED REPLACEMENT OF THE CPU BOARD. CUSTOMER DECLINED CO2 REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO SPO2 FUNCTION ON THE SPECTRUM MONITOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186677 SPECTRUM MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1