BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTORR PLUS MONITOR

    MDR report key: 3832020 · Received March 7, 2014

    Report

    Report Number
    2221819-2014-00080
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 24, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    983575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE SYSTEM. CORRECTION INCLUDES REPLACEMENT OF THE SPO2 BOARD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE ACCUTORR PLUS MONITOR, WHICH MAY HAVE AFFECTED SPO2 MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138634 ACCUTORR PLUS MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1