BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT MONITOR

    MDR report key: 5832256 · Received July 29, 2016

    Report

    Report Number
    3003971136-2016-00003
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    June 20, 2016
    Report Date
    July 29, 2016
    Manufacturer
    EDAN INSTRUMENTS, INC.
    Product Code
    MHX
    PMA / PMN Number
    K131971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EDAN INSTRUMENTS INVESTIGATED THAT THE LOW VALUES WERE PRIMARILY DUE TO INACCURATE CALIBRATION PERFORMED AT THE FACTORY. NOTIFICATION WAS SENT TO THE DISTRIBUTORS OF THE PRODUCTS, AND CORRECTIONS INCLUDES REPLACEMENT OF CO2 MODULE. THE AFFECTED UNIT WAS TESTED FOR THE NON-STABLE READINGS DURING USAGE. DURING TESTING, THE UNIT WORKED AS INTENDED WITH STABLE VALUES. INVESTIGATION WILL CONTINUE TO DETERMINE IF DEVICE MALFUNCTION OCCURRED, OR IF THERE WAS USER ERROR DURING THIS FIRST USAGE OF THE DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE INCORRECT CO2 READING DURING DENTAL ANESTHESIA USAGE. CO2 READINGS WERE BOTH LOW AND NOT STABLE, OCCASIONALLY GOING TO ZERO. DUE TO THE LOW VALUES, THE PATIENT WAS TRANSFERRED A LOCAL HOSPITAL TO BE WEANED OFF OF ANESTHESIA. NO SEQUELAE WERE OBSERVED AND THERE WERE NO ADVERSE EVENTS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485188 PATIENT MONITOR PATIENT MONITOR MHX EDAN INSTRUMENTS, INC. IM60

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| O