BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTORR V MONITOR

    MDR report key: 4090073 · Received August 18, 2014

    Report

    Report Number
    2221819-2014-00481
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    091068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENTS OF THE UNIT'S SPO2 BOARD AND LCD PANEL. UNIT WAS CALIBRATED AND WAS TESTED TO FACTORY'S SPECS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496306 ACCUTORR V MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1