BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8, HORIZONTAL

    MDR report key: 4932640 · Received July 17, 2015

    Report

    Report Number
    2031172-2015-00942
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 17, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING THIS TESTING THE UNIT WAS NOT ABLE TO PERFORM FUNCTIONAL AND ALARM TEST BECAUSE THERE WAS NO POWER SUPPLYING THE UNIT. A LOOSE SCREW AND A DAMAGED SOLDER CONNECTION ON THE SYSTEM BOARD WAS OBSERVED. THE SYSTEM BOARD WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FILED FOR OVER FOUR (4) YEARS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNITS TURN OFF AFTER A FEW MINUTES WITHOUT ANY WARNING. THE CUSTOMER ALSO REPORTED NO ALARM BEING HEARD BEFORE UNITS SHUT OFF. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465901 RAD-8, HORIZONTAL OXIMETER DQA MASIMO CORPORATION 22595

    Patients

    Seq Age Sex Outcome Treatment
    1