BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROOT

    MDR report key: 6665829 · Received June 24, 2017

    Report

    Report Number
    2031172-2017-00667
    Event Type
    Malfunction
    Date Received
    June 24, 2017
    Date of Event
    May 30, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED BY THE CUSTOMER THAT ALL UNITS USED DURING THE REPORTED EVENT WERE AFFECTED; AND THEREFORE, WILL NOT BE RETURNED TO MASIMO FOR EVALUATION. TECHNICAL SUPPORT WILL PERFORM AN ONSITE INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED. NO PATIENT INCIDENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    AN ON-SITE ASSESSMENT WAS PERFORMED BY MASIMO CLINICAL STAFF TO VERIFY THAT APPROPRIATE EQUIPMENT WAS USED BASED ON SPECIFIC PATIENT PROFILE AND CATEGORY. EDUCATION WAS PROVIDED TO THE CUSTOMER'S NEONATAL STAFF SINCE THIS WAS THE MAIN AREA THAT RESULTED WITH ERRORS. THE PRODUCT INVOLVED IN THIS EVENT HAVE NOT BEEN RETURNED TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. DEVICE EVALUATED BY MANUFACTURER FROM "NO; DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN" TO "NOT RETURNED TO MANUFACTURER".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEDICAL STAFF OF WARD B/ C AND EMD ARE REPORTING DIFFERENT MEASUREMENT ISSUES RELATED ROOT VS NIPB VALUES. SUNTECH NIPB TECHNOLOGY IS MEASURING MUCH HIGHER VALUES (SYST & DIAST.) COMPARED TO HAND MEASURED BP AND DINAMAP. (RE-)CALIBRATION / INVESTIGATION SERVICE NEEDS TO BE DONE ASAP. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446387 ROOT OXIMETER DQA MASIMO - 40 PARKER 25218

    Patients

    Seq Age Sex Outcome Treatment
    1