BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOT

    MDR report key: 4092977 · Received September 5, 2014

    Report

    Report Number
    2031172-2014-00175
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K091057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND ADD'L INFO REQUESTS WERE MADE. HOWEVER, THE DEVICE WAS NOT MADE AVAILABLE TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF AND WHEN INFO BECOMES AVAILABLE OR ONCE THE UNIT IS RETURNED AND AN EVAL IS PERFORMED, A FOLLOW UP REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND IT WAS DETERMINED THAT THE DEVICE MET ALL RELEASE CRITERIA. NO PT INCIDENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE SPHB NUMBERS ARE READINGS UP TO THREE POINT EITHER TOO HIGH, OR TOO LOW. THE CUSTOMER INDICATED THAT THIS UNIT WAS RECENTLY RECEIVED BACK FROM BEING SERVICED/UPGRADED. NO PT INCIDENT REPORTED, AND WILL ENGAGE IN MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545827 PRONOT DQA MASIMO CORPORATION 9167

    Patients

    Seq Age Sex Outcome Treatment
    1