BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-G

    MDR report key: 18420621 · Received December 29, 2023

    Report

    Report Number
    3019388613-2023-00283
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    January 1, 1901
    Report Date
    December 6, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED RAD-G WAS EVALUATED. THE DEVICE WAS ABLE TO POWER ON AND OFF VIA BATTERY AND AC POWER. THE CUSTOMER REPORTED POWER OFF ISSUE WAS NOT OBSERVED.

    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.

    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 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

    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 ON AND OFF SPONTANEOUSLY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286112 RAD-G OXIMETER DQA MASIMO - 15750 ALTON PKWY 9849 00843997000666

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown