BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-97 PULSE CO-OXIMETER

    MDR report key: 17148811 · Received June 16, 2023

    Report

    Report Number
    3011353843-2023-00155
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    January 1, 1901
    Report Date
    May 22, 2023
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    MWI
    UDI-DI
    00843997012317
    PMA / PMN Number
    K170168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. A CONTAMINATED U8 COMPONENT ON THE INSTRUMENT BOARD CAUSED THE SHARED SDA AND SCL DATA LINES ON THE U13 AUDIO CHIP TO NOT FUNCTION PROPERLY. THIS RESULTED IN THE "AUDIO SPEAKER FAULT" BEING TRIGGERED WHEN THE DEVICE WAS POWERED UP AND PREVENTED THE SPEAKER FROM FUNCTIONING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: 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 RAD-97 PROVIDED "NO ALARM." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE RAD-97 PROVIDED "NO ALARM." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679625 RAD-97 PULSE CO-OXIMETER MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 15750 ALTON PKWY 27573 00843997012317

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown