Nellcor FLEXMAXRecalls & reported problems
Covidien LP · Flexible SpO2 Sensor, Reusable · Class 2
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521532304), received between Aug 22, 2018 and Sep 19, 2024 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Low Readings” (20 reports).
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 Readings20
- Delayed Program or Algorithm Execution1
Patient problems
- No Consequences Or Impact To Patient19
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2024Low Readings; Delayed Program or Algorithm Execution; Low Readings; Delayed Program or Algorithm Execution
ACCORDING TO THE REPORTER, DURING USE, THE SENSOR HAD A READING EVEN WHEN NOT ON THE PATIENT. THE PATIENT WITH A TRACHEOSTOMY AND A HIGH RISK OF DECANNULATION WAS HAVING SPO2 MONITORED USING THE EAR CLIP SENSOR. THE NURSE NOTED THAT THE SPO2 WAS LOW AT 86% AS THEY WALKED PAST THE BED SPACE AND THEN NOTICED THAT THE SENSOR WAS ON THE PILLOW NEXT TO THE PATIENT'S CHEEK BUT WAS STILL SHOWING A TRACE AND SPO2 OF 86%. LATER THAT DAY, THE EAR CLIP SENSOR WAS FOUND IN THE PATIENT'S HAND, AND IT WAS STILL PICKING UP A TRACE AND A READING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20256929 ↗MalfunctionAug 27, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7819463 ↗MalfunctionAug 27, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7819059 ↗MalfunctionAug 27, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7818980 ↗MalfunctionAug 27, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7818955 ↗MalfunctionAug 23, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7808750 ↗MalfunctionAug 23, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7808743 ↗MalfunctionAug 23, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7808735 ↗MalfunctionAug 23, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7808701 ↗MalfunctionAug 23, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7808693 ↗MalfunctionAug 23, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7808630 ↗MalfunctionAug 23, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7808621 ↗MalfunctionAug 23, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7808598 ↗MalfunctionAug 23, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7808578 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807262 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807253 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807204 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807166 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807164 ↗MalfunctionAug 22, 2018Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING AND THERE HAD BEEN DELAYS WITH SENSORS PICKING UP SPO2. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807163 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.