BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-G

    MDR report key: 19922341 · Received August 6, 2024

    Report

    Report Number
    3019388613-2024-00106
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 12, 2024
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    DQA
    UDI-DI
    00843997013284
    PMA / PMN Number
    K201770
    Removal / Correction Number
    Z-1537-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THE RETURNED DEVICE WAS INVESTIGATED AND IT WAS CONFIRMED THERE WAS A SHORT INSIDE THE POWER BUTTON. THIS RESULTED IN THE ON/OFF BUTTON BEING ACTIVATED WHEN NOT PHYSICALLY PRESSED. MASIMO INITIATED A RECALL FOR THIS ISSUE AND NOTIFIED US FDA ON 02/15/2024. THE RECALL NUMBER IS Z-1537-2024.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE RAD-G DOES NOT STAY ON CONTINUOUSLY. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770659 RAD-G OXIMETER DQA MASIMO - 15750 ALTON PKWY 9847 00843997013284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown