BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-G

    MDR report key: 18036219 · Received October 30, 2023

    Report

    Report Number
    3019388613-2023-00263
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    January 1, 1901
    Report Date
    October 5, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: OTHER TEXT: THE RETURNED RAD-G WAS EVALUATED. THE DEVICE DISPLAY BECAME DISTORTED PRIOR TO THE UNIT POWERING OFF BY ITSELF. THE DISPLAY AND POWER ISSUE WAS CAUSED BY A DEFECTIVE COMPONENT ON THE CIRCUIT BOARD.

    Additional Manufacturer Narrative · 0

    MASIMO'S INITIAL REPORT IDENTIFIED THE MODEL AS NUMBER 27977. MODEL NUMBER 9849 IS ASSOCIATED WITH THE GUDID NUMBER. PART NUMBER 227977 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

    OTHER TEXT: **UDI RELATED DATA QUALITY UPDATES ONLY** THIS CORRECTION INCLUDES THE ENTIRE UDI NUMBER INCLUDING THE DI AND PI FIELDS, ALL NUMBERS, LETTERS, PARENTHESES, AND SYMBOLS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE "RAD-G TURNS ON AND OFF BY ITSELF." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE "RAD-G TURNS ON AND OFF BY ITSELF". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE "RAD-G TURNS ON AND OFF BY ITSELF." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981920 RAD-G OXIMETER DQA MASIMO - 15750 ALTON PKWY 9849 00843997000666

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown