BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM MONITOR

    MDR report key: 4122199 · Received September 18, 2014

    Report

    Report Number
    2221819-2014-00551
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 28, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    062098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF THE UNIT'S CO2 MODULE, POWER SUPPLY, SPO2 CABLE, AND RECONNECTING THE DISPLAY CABLE TO THE INVERTER BOARD. UNIT WAS CALIBRATED AND TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE SPECTRUM MONITOR, WHICH MAY HAVE AFFECTED SPO2 MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579060 SPECTRUM MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1