BEUDAMED
    FDA Adverse Event Death Summary report: N

    3880 MRI PATIENT MONITORING SYSTEM

    MDR report key: 21233576 · Received January 24, 2025

    Report

    Report Number
    3005053560-2024-00008
    Event Type
    Death
    Date Received
    January 24, 2025
    Date of Event
    December 26, 2024
    Report Date
    January 24, 2025
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    MWI
    UDI-DI
    00856038001331
    PMA / PMN Number
    K180903
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT INVOLVED THE PATIENT MONITOR S/N (B)(6). FOLLOWING THE INITIAL REPORT, IRADIMED CONTACTED THE BIOMEDICAL ENGINEER, WHO INDICATED THAT THE DEVICE HAD BEEN REMOVED FROM SERVICE FOR INVESTIGATION. THE CUSTOMER STATED THAT THEY TROUBLESHOT THE DEVICE, CONDUCTED FUNCTIONAL TESTS, BUT WERE UNABLE TO REPLICATE THE FAILURE MODE. BASED ON THE BIOMEDICAL ENGINEERING ASSESSMENT, THE DEVICE WAS OPERATING AS EXPECTED. THE DEVICE WAS RETURNED TO IRADIMED FOR EVALUATION AND A REVIEW OF OPERATIONAL DETAILS. IT WAS EVALUATED ON 01/16/2025, DURING WHICH A PHYSICAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. NO MALFUNCTIONS WERE IDENTIFIED. IRADIMED WAS UNABLE TO DUPLICATE THE REPORTED FAILURE MODE, AS THE EQUIPMENT OPERATED AS DESIGNED AND EXPECTED. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST THAT THE DEVICE (3880) MALFUNCTIONED, AS NO EVIDENCE OF A MALFUNCTION WAS FOUND. THE CUSTOMER CONFIRMED THAT THE ICU PATIENT HAD A PREEXISTING CONDITION, "ALCOHOL-INDUCED ENCEPHALOPATHY," WHICH MIGHT HAVE CONTRIBUTED TO THE OUTCOME. THEREFORE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF THE USER PROVIDES ADDITIONAL DETAILS DURING THE INVESTIGATION, AN MDR SUPPLEMENT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN EVENT INVOLVING AN IRADIMED PATIENT MONITOR. ACCORDING TO THE CUSTOMER, AN ICU PATIENT WAS TRANSFERRED TO THE MRI, AND THE MONITOR INTERMITTENTLY LOST SIGNALS (ECG, NIBP) DURING THE MRI PROCEDURE. THEY ATTEMPTED TROUBLESHOOTING AND SWITCHED THE NIBP CUFF TO THE OTHER ARM BUT CONTINUED TO EXPERIENCE INTERMITTENT SIGNALS. THE CUSTOMER ALSO REPORTED THAT THE DEVICE SCREEN WENT COMPLETELY BLANK FOR APPROXIMATELY 5 SECONDS. THE PATIENT WAS 87 YEARS OLD AND HAD PREEXISTING CONDITIONS (ENCEPHALOPATHY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140944 3880 MRI PATIENT MONITORING SYSTEM MONITOR, PATIENT MWI IRADIMED CORPORATION 3880 00856038001331

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Unknown Death