MAUDE Adverse Event Report: IRADIMED CORPORATION 3880 MRI PATIENT MONITOR SYSTEM; MONITOR, PATIENT

Model Number	3880
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The accumulation of radio frequency (rf) energy, a byproduct of an mri scan sequence, can cause burns, as shown in the photo (provided by the customer), when areas of large mass undergo mr imaging.Mr imaging of large-mass areas requires high levels of rf energy.A loop in a conductive cable inside the mri bore or a conductor touching both the patient and the mri bore can act as an antenna and absorb this rf energy.The energy is then dissipated from the cable in the form of heat; in this case, the cable subsequently burned the patient.The iradimed 3883 (ippod) invasive blood pressure module interfaces with the hospital's invasive pressure transducers, which contain conductive cabling.The customer did not provide information on the location of the bp transducer during the event.It is highly possible that the hospital's invasive blood pressure transducer cable was placed in the mr bore, resulting in the patient burn.However, while the device is available for evaluation and a request has been made to examine the pod, cable, transducer, etc., the customer has not yet returned it.Warnings and precautions related to rf burns are included in the mri use precautions, mri compatibility, ecg section, and invasive blood pressure (ibp) section of the iradimed 3880 mri patient monitoring system operations manual (part number 1200).Below, under "additional information," is the warning from the invasive blood pressure section (6.6.1) of the operations manual.The warning clearly states never to place the pressure transducer or invasive blood pressure (ibp) cable within the mr bore.The customer stated that the patient suffered a third-degree burn.The patient was evaluated by a surgeon, who determined that no medical intervention was needed beyond topical treatment.However, because the event resulted in a patient injury, iradimed is reporting this mdr.When the customer returns the device for evaluation and additional information becomes available, an mdr supplement will be submitted.
Event or Problem Description
It was reported that the customer experienced an event involving a 3883 an ippod.According to the radiology director, the patient suffered a third-degree burn that required treatment with topical medication.The patient was evaluated by a surgeon, and surgery or other medical intervention was ruled out.The device is available for evaluation.

• Brand Name: 3880 MRI PATIENT MONITOR SYSTEM
• Common Device Name: MONITOR, PATIENT
• Manufacturer (Section D): IRADIMED CORPORATION; 1025 willa springs drive; winter springs FL 32708
• Manufacturer (Section G): IRADIMED CORPORATION; 1025 willa springs drive; winter springs FL 32708
• Manufacturer Contact: leonardo aldarondo ; 1025 willa springs drive; winter springs, FL 32708
• MDR Report Key: 21690596
• Report Number: 3005053560-2025-00002
• Device Sequence Number: 15807501
• Product Code: MWI
• UDI-Device Identifier: 00856038001379
• UDI-Public: 0100856038001379
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K180903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 3880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown