BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAD-5 HANDHELD

    MDR report key: 4997221 · Received August 12, 2015

    Report

    Report Number
    2031172-2015-01003
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K033296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING FUNCTIONAL TESTING, THE SETTINGS WERE ADJUSTED AND THE UNIT SHOWED INABILITY TO SAVE THE DESIRED ADJUSTED SETTINGS. UPON INTERNAL INSPECTION OF THE DEVICE, NO INTERNAL CIRCUITRY DAMAGE OR DEFECTS OBSERVED, HOWEVER, UPON INSTALLING A KNOWN GOOD SYSTEM BOARD INTO THE CUSTOMER'S DEVICE, THE USER SETTINGS COULD BE SAVED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER TWENTY (20) MONTHS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER REPLACEMENT DEVICE WILL NOT HOLD SETTINGS AFTER THEY HAVE BEEN SET AND SAVED. THE CUSTOMER ALSO MENTIONED THAT DURING THIS TIME SHE NOTICED HER DAUGHTER TURNED BLUE, AND HER EYES WERE DILATED. ADDITIONAL INFORMATION RECEIVED DEVICE DIDN'T ALARM WHEN SHE WAS OBVIOUSLY LACKING OXYGEN. PATIENT IS (B)(6). SHE'S HOOKED UP TO A PULSE OX 24/7 AND IS VENTILATOR DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528778 RAD-5 HANDHELD OXIMETER DQA MASIMO CORPORATION 22330

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other