BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-57

    MDR report key: 5408967 · Received February 3, 2016

    Report

    Report Number
    2031172-2016-00103
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 10, 2016
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K080238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION, THE SPEAKER WAS RASPY AND CONTAMINATION WAS FOUND ON THE SYSTEM BOARD; HOWEVER, THESE FINDINGS DO NOT AFFECT THE CUSTOMER COMPLAINT. THE DEVICE WAS ABLE TO OBTAIN SPCO VALUES AND THE VALUES WERE WITHIN SPECIFICATIONS. THE DEVICE PASSED ALL FUNCTIONAL TESTING, AND WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. NO PRODUCT PERFORMANCE ISSUES RELATED TO THE COMPLAINT WERE IDENTIFIED, AND BASED ON THE INVESTIGATION ABOVE, THE CUSTOMER COMPLAINT COULD NOT BE DUPLICATED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER THREE (3) 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 THAT THE BIOMED GUYS TESTED THE RAD-57 AND ONE OF THE GUYS HAD SPCO MEASUREMENT OF 12 AND THE OTHER ONE HAD SPCO MEASUREMENT OF 3. LINE FREQUENCY IS PROPERLY CONFIGURED TO 50 HZ (THE ONE USED IN SPAIN). THERE WERE NO CONSEQUENCES OR IMPACT TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65392 RAD-57 OXIMETER DQA MASIMO CORPORATION 25195

    Patients

    Seq Age Sex Outcome Treatment
    1