BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTORR PLUS II MONITOR

    MDR report key: 3091098 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00876
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    DXN
    PMA / PMN Number
    983575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPRESENTATIVES REPLACED THE SPO2 MAIN BOARD, RAN SYSTEM DIAGNOSTICS TO FACTORY SPECIFICATIONS AND PERFORMED SAFETY TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE ACCUTORR PLUS MONITOR, WHICH MAY HAVE RESULTED IN LOSS OF SPO2 MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188012 ACCUTORR PLUS II MONITOR PATIENT MONITOR DXN MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1