BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL 7 COLOR SCREEN HANDHELD

    MDR report key: 6572999 · Received May 17, 2017

    Report

    Report Number
    2031172-2015-00156
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    September 10, 2014
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(6).

    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 TOUCH SCREEN 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 SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER 5 MONTHS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR # WAS 2031172-2014-00325. HOWEVER, THE CORRECT MDR # SHOULD BE 2031172-2015-00156.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH SCREEN DOES NOT "RESPOND" AND HAS INTERMITTENT FUNCTION. THE CUSTOMER STATES THE RADICAL TURNS OFF ON ITS OWN. THE UNIT'S LANGUAGE SETTINGS ALSO CHANGE SPONTANEOUSLY TO MANDARIN CHINESE AND CANNOT BE RETURNED TO (B)(6) DUE TO THE LACK OF TOUCH SCREEN FUNCTIONALITY. THIS UNIT DOES NOT ENGAGE IN PATIENT MONITORING. NO FURTHER DETAILS AVAILABLE. NO PATIENT INCIDENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352623 RADICAL 7 COLOR SCREEN HANDHELD OXIMETER DQA MASIMO - 40 PARKER 23786

    Patients

    Seq Age Sex Outcome Treatment
    1