BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-G

    MDR report key: 20477283 · Received October 17, 2024

    Report

    Report Number
    3019388613-2024-00125
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    January 1, 2024
    Report Date
    September 19, 2024
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    DQA
    UDI-DI
    00843997013284
    PMA / PMN Number
    K213676
    Removal / Correction Number
    Z-1537-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: MASIMO HAS REACHED OUT TO THE CUSTOMER TO REQUEST THE RETURN OF THE DEVICE. 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. MASIMO INITIATED A RECALL FOR THIS ISSUE AND NOTIFIED US FDA ON 2/15/2024. THE RECALL NUMBER IS Z-1537-2024. E1. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6). E1. INITIAL REPORTER PHONE NUMBER EXCEEDED MAXIMUM ALLOWABLE DIGITS; PHONE NUMBER IS AS FOLLOWS: (B)(6).

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE DEVICE WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE DEVICE WAS CONFIRMED TO BE FUNCTIONING AS DESIGNED. MASIMO INITIATED A RECALL FOR THIS ISSUE AND NOTIFIED US FDA ON 2/15/2024. THE RECALL NUMBER IS Z-1537-2024. THIS SUPPLEMENTAL FORM ALSO UPDATES THE 510K NUMBER FOR THIS DEVICE FROM K201770 TO K213676. E1. INITIAL REPORTER: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED "UNITS SWITCHING ON/OFF". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED "UNITS SWITCHING ON/OFF". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243557 RAD-G OXIMETER DQA MASIMO - 15750 ALTON PKWY 9847 00843997013284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown