BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT MONITOR

    MDR report key: 5801005 · Received July 16, 2016

    Report

    Report Number
    3003971136-2016-00002
    Event Type
    Malfunction
    Date Received
    July 16, 2016
    Date of Event
    June 16, 2016
    Report Date
    July 14, 2016
    Manufacturer
    EDAN INSTRUMENTS,INC
    Product Code
    MHX
    PMA / PMN Number
    K113653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    EDAN INSTRUMENTS INVESTIGATED THAT THE ERROR WAS DUE TO INACCURATE CALIBRATION PERFORMED AT THE FACTORY. NOTIFICATION WAS SENT TO THE DISTRIBUTORS OF THE PRODUCTS, AND CORRECTIONS INCLUDES REPLACEMENT OF CO2 MODULE

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE LOW INCORRECT READING, WHICH MAY AFFECT PATIENT MONITORING. NO PATIENT DEATH OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453816 PATIENT MONITOR PATIENT MONITOR MHX EDAN INSTRUMENTS,INC IM8B

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other