Nellcor DLPM100NRecalls & reported problems
Covidien LP · Bedside SpO2 Patient Monitoring System, PM100N · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521527607), received between Dec 12, 2023 and Dec 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 23, 2025Open, Classified
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
Z-2151-2025 · Root cause: Labeling design · FDA record ↗
Most reported problems
Device problems
- Device Alarm System1
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.
MalfunctionDec 12, 2023Device Alarm System; Device Alarm System
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WOULD NOT ALARM ON LOW OXYGEN LEVEL BUT ALARMED FINE ON DME (DURABLE MEDICAL EQUIPMENT) PERSONNEL. THE UNIT WAS SWAPPED OUT WITH REPLACEMENT WHICH DID THE SAME THING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18314303 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.