MAUDE Adverse Event Report: IRADIMED CORP. IRADIMED; PUMP, INFUSION

Model Number	3860+
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient transferred with known emergent large vessel occlusion (elvo) from outside of hospital.Patient presented to mri for hyperacute mri, rapid intubated.Patient required mri compatible pump, which was malfunctioning for a half hour, delaying the mri and patient's care.

• Brand Name: IRADIMED
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): IRADIMED CORP.; 1025 willa springs dr; winter springs FL 32708
• MDR Report Key: 8023585
• Report Number: 8023585
• Device Sequence Number: 1369231
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: (01)00856038001089
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/25/2018
• Report Date (Section F): 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3860+
• Device Catalogue Number: 3860+
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/25/2018