BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-97 W/NIBP

    MDR report key: 12328379 · Received August 16, 2021

    Report

    Report Number
    3011353843-2021-00202
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    July 20, 2021
    Report Date
    July 23, 2021
    Product Code
    MWI
    UDI-DI
    00843997012775
    PMA / PMN Number
    K170168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. VISUAL INSPECTION FOUND THE DISPLAY LAYERS WERE ADHERED TOGETHER WHICH DID NOT AFFECT VISIBILITY OF THE DISPLAY. THE UNIT PASSED ALL FUNCTIONALITY TESTING AND WAS ABLE TO OBTAIN MEASUREMENTS WITH ALL THE ENABLED PARAMETERS. THE COMPARISON TEST WAS PERFORMED AND PASSED SIMULATION AND LEAK TESTING. NO PRODUCT PERFORMANCE ISSUE IDENTIFIED RELATED TO NIBP. THE DEVICE FUNCTIONS AS DESIGNED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. VISUAL INSPECTION FOUND THE DISPLAY LAYERS WERE ADHERED TOGETHER WHICH DID NOT AFFECT VISIBILITY OF THE DISPLAY. THE UNIT PASSED ALL FUNCTIONALITY TESTING AND WAS ABLE TO OBTAIN MEASUREMENTS WITH ALL THE ENABLED PARAMETERS. THE COMPARISON TEST WAS PERFORMED AND PASSED SIMULATION AND LEAK TESTING. NO PRODUCT PERFORMANCE ISSUE IDENTIFIED RELATED TO NIBP. THE DEVICE FUNCTIONS AS DESIGNED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INACCURATE PNI VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INACCURATE PNI VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT 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 INACCURATE PNI VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222104 RAD-97 W/NIBP OXIMETER MWI 26245 00843997012775

    Patients

    Seq Age Sex Outcome Treatment
    1