BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS-7 WI-FI KIT

    MDR report key: 14123270 · Received April 15, 2022

    Report

    Report Number
    3019388613-2022-00095
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 22, 2022
    Report Date
    March 25, 2022
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    DQA
    UDI-DI
    00843997014106
    PMA / PMN Number
    K183697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    THE CUSTOMER REPORTED THE VITALS DROP OUT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415179 RADIUS-7 WI-FI KIT OXIMETER DQA MASIMO - 15750 ALTON PKWY 27743 00843997014106

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown