Nellcor DLN560Recalls & reported problems
Covidien LP · PULSE OXIMETER · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521582484), received between Aug 23, 2019 and Dec 2, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (2 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.
Most reported problems
Device problems
- Device Alarm System2
- Poor Quality Image1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2019Poor Quality Image; Poor Quality Image
ACCORDING TO THE REPORTER, THE DEVICE DOES NOT MARK THE DIGITS WELL. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9398110 ↗MalfunctionNov 7, 2019Device Alarm System; Device Alarm System
ACCORDING TO THE REPORTER, THE UNIT HAD AN ISSUE WITH THE ALARM. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9293592 ↗MalfunctionAug 23, 2019Device Alarm System; Device Alarm System
ACCORDING TO THE REPORTER, THE DEVICE HAD ALARM DEFECT. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8928373 ↗
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- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
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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