Iradimed 3880-3Recalls & reported problems
Iradimed Corp. · 3880 MRI Basic Monitor System + ETCO2 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00856038001331), received between Jan 24, 2025 and Jan 24, 2025 — classified as 1 death.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Encephalopathy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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).
Patient problems: Encephalopathy
MAUDE report 21233576 ↗
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- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls5 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls3 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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