BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-57 CONFIGURABLE PULSE CO-OXIMETER

    MDR report key: 8729702 · Received June 24, 2019

    Report

    Report Number
    2031172-2019-00307
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 4, 2019
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K080238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. DURING SIMULATION TESTING, THE DEVICE PASSED MANUAL AND PRESET CONDITIONS AND PROVIDED ACCURATE MEASUREMENTS. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED., CORRECTED DATA: D1 BRAND NAME WAS CORRECTED FROM KIT, RAD-97 PULSE CO-OXIMETER TO RAD-57 CONFIGURABLE PULSE CO-OXIMETER D2 PRODUCT CODE WAS CORRECTED FROM MWI TO DQA D4 MODEL # WAS CORRECTED FROM 26243 TO 25195. D4 CATALOG # WAS CORRECTED FROM 9738 TO 9216. G5 PMA/510(K) WAS CORRECTED FROM K170168 TO K080238.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE DOES NOT PROVIDE ANY MEASUREMENT AND THE SPCO VALUE ARE INACCURATE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DOES NOT PROVIDE ANY MEASUREMENT AND THE SPCO VALUE ARE INACCURATE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521502 RAD-57 CONFIGURABLE PULSE CO-OXIMETER OXIMETER DQA MASIMO - 40 PARKER 25195

    Patients

    Seq Age Sex Outcome Treatment
    1