BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4D DC SENSOR, MEDIUM

    MDR report key: 4250098 · Received August 22, 2013

    Report

    Report Number
    2031172-2014-00144
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 10, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K111403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY ARE UNHAPPY WITH SPHB TEST RESULTS ON THE PRONTO-7. IT HAS BECOME EXTREMELY SENSITIVE AND IT IS NOT POSSIBLE TO OBTAIN HEMOGLOBIN RESULTS ON PATIENTS. ADD'L INFO WAS MADE AVAILABLE ON (B)(6) 2014: IN GENERAL THE PRONTO 7 IS SENSITIVE TO MOTION. THE CUSTOMER STATED THAT IT WAS GIVING INACCURATE READINGS. NO PT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409493 4D DC SENSOR, MEDIUM DQA MASIMO CORPORATION 9401

    Patients

    Seq Age Sex Outcome Treatment
    1