CARDINAL HEALTH E501RASRRecalls & reported problems
Cardinal Health 200, LLC · Monitoring Electrode, RT Snap, Repositionable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30885380048399), received between Jun 16, 2017 and Jun 16, 2017 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT REPORTEDLY SUSTAINED A BURN FROM THE MONITORING ELECTRODES WHEN HIS MRI WAS DONE. THE PATIENT HAD JUST COME FROM THE ED TO THE NURSING UNIT. THERE WAS NO SERIOUS INJURY, BUT SOME OF THE STAFF ARE REPORTING THAT THEY THOUGHT THE ELECTRODES DIDN'T HAVE METAL SO WERE OKAY TO LEAVE THEM ON.
Patient problems: Burn(s)
MAUDE report 6647749 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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