BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7 HANDHELD

    MDR report key: 4092999 · Received September 5, 2014

    Report

    Report Number
    2031172-2014-00176
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K100428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING THIS TESTING THE UNIT WAS ABLE TO POWER ON HOWEVER, DIFFERENT SCREENS WERE DISPLAYED RANDOMLY AND SOME OF TOUCHSCREEN ICONS WERE NOT ABLE TO BE SELECTED (UNRESPONSIVE) DUE TO A DEFECTIVE TOUCHSCREEN ASSEMBLY. THE DEVICE WAS ABLE TO OBTAIN READINGS FROM SENSOR AND TESTER HOWEVER, THE DEVICE CANNOT BE USED FOR MONITORING DUE TO THE SCREEN CHANGING. THE AUDIBLE AND VISUAL STATUS INDICATORS WERE FUNCTIONING. A REVIEW OF THE HISTORY FOR THIS DEVICE WAS PERFORMED AND IT WAS CONCLUDED THAT THE DEVICE WAS IN THE FIELD FOR OVER ONE (1) YEAR WITH NO PREVIOUS RETURNS FOR SERVICING OR OTHER ISSUES PRIOR TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TOUCH SCREEN ACTS LIKE IT IS NOT WORKING CORRECTLY. IT ACTS LIKE IT IS BEING TOUCHED WHEN IT IS NOT. NO PT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545949 RADICAL-7 HANDHELD DQA MASIMO CORPORATION 9500

    Patients

    Seq Age Sex Outcome Treatment
    1