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

Model Number	3880
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Encephalopathy (1833)
Date of Event	12/26/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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).

• Brand Name: 3880 MRI PATIENT MONITORING 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: 21233576
• Report Number: 3005053560-2024-00008
• Device Sequence Number: 15610964
• Product Code: MWI
• UDI-Device Identifier: 00856038001331
• UDI-Public: 0100856038001331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (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: Death
• Patient Age: 87 YR
• Patient Sex: Unknown