BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-G

    MDR report key: 17882961 · Received October 5, 2023

    Report

    Report Number
    3019388613-2023-00256
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    July 6, 2023
    Report Date
    September 12, 2023
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    DQA
    UDI-DI
    00843997000666
    PMA / PMN Number
    K201770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED RAD-G WAS EVALUATED. THE ISSUE WAS CAUSED BY SHORTING INSIDE THE ON/OFF POWER BUTTON WHICH CREATED AN ELECTRICAL SHORT ACROSS THE BUTTON, AND RESULTED IN THE BUTTON BEING ACTIVATED EVEN WHEN NOT PHYSICALLY PRESSED.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: MASIMO'S INITIAL REPORT IDENTIFIED THE MODEL AS NUMBER 27977. MODEL NUMBER 9849 IS ASSOCIATED WITH THE GUDID NUMBER. PART NUMBER 27977 IS THE SUBASSEMBLY TO PART NUMBER 9849. THIS SUPPLEMENTAL MDR UPDATES THE MODEL NUMBER TO 9849 AND BRAND NAME TO RAD-G TO ENSURE CORRELATION WITH THE GUDID DATABASE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION UPDATES THE UDI NUMBER TO INCLUDE THE DI AND PI FIELDS, ALL NUMBERS, LETTERS, PARENTHESES, AND SYMBOLS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE RAD-G TURNS OFF AND ON RANDOMLY. THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEIR RAD-G DEVICE TURNS OFF AND ON RANDOMLY. THERE WAS NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEIR RAD-G DEVICE TURNS OFF AND ON RANDOMLY. THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEIR RAD-G DEVICE TURNS OFF AND ON RANDOMLY. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225348 RAD-G OXIMETER DQA MASIMO - 15750 ALTON PKWY 9849 00843997000666

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown