BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8, HORIZONTAL

    MDR report key: 6012801 · Received October 7, 2016

    Report

    Report Number
    2031172-2016-01089
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING INSPECTION OF THE DEVICE, THE UNIT WAS FOUND TO DISPLAY ¿ERROR 1," THEN RESET. ANALYSIS OF THE REPLACED TECHNOLOGY BOARD INDICATED LDO REGULATORS U57 AND U58 ARE WERE NOT POWERING ON DUE TO A LOW SHUTDOWN ENABLE SIGNAL COMING FROM MICROPROCESSOR U14 FLAG0. THE TECHNOLOGY BOARD WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER FOUR (4) YEARS WITH NO PREVIOUS REPORTED ISSUES RELATED TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "ALL THE MEASUREMENTS ALWAYS READ LOW." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661823 RAD-8, HORIZONTAL OXIMETER DQA MASIMO - 40 PARKER 22042

    Patients

    Seq Age Sex Outcome Treatment
    1