BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL 7

    MDR report key: 4368110 · Received December 18, 2014

    Report

    Report Number
    2031172-2014-00551
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 20, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO FOR EVALUATION. TROUBLESHOOTING WAS PERFORMED WITH THE CUSTOMER AND IT WAS DETERMINED THAT THE "AVERAGING TIME" SETTING ON THEIR DEVICE NEEDED TO BE ADJUSTED TO ADDRESS THE REPORTED ISSUE. AFTER ADJUSTING THIS SETTING, THE ISSUE HAS BEEN RESOLVED. 510(K) # UPDATED TO K110028

    Additional Manufacturer Narrative · 1

    ATTEMPT FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFO WERE MADE. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFO IS OBTAINED OR THE PRODUCT IS RETURNED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PERFORMING A HISTOGRAM AUDIT THE VALUES WERE INACCURATE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833905 RADICAL 7 OXIMETER DQA MASIMO CORPORATION 23786

    Patients

    Seq Age Sex Outcome Treatment
    1