BIS 186-0160Recalls & reported problems
Covidien LP · Extend Sensor · Class 2
- 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 20884521657837), received between Jan 31, 2024 and Jan 31, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Readings” (1 report).
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
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE SENSOR WERE USED WITH THE MODULES AND STAND ALONE MONITORS AND THE SENSORS FAILED ON ALL OF THEM. THE READING WAS TOO LOW AND THE CUSTOMER SAID THAT THERE WERE NOT EVEN ON THE FOREHEAD PROPERLY AND STARTED READING A BIS OF BELOW 30. WHEN IT WERE IN THE CORRECT PLACE, THE READING WAS BELOW 30 EVEN THOUGH THE PATIENT WERE VERY LIGHTY SEDATED. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619186 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.