Medline MDSVSMN1Recalls & reported problems
Medline Industries, Inc. · MONITOR, BP, SPO2 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489012903), received between Sep 24, 2026 and Sep 24, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K180380); they may or may not involve this specific model.
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
- Incorrect, Inadequate or Imprecise Result or Readings2
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891638 ↗MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that the spo2 is not working.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881973 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K180380. One submission often covers many models, so check the product and lot details in each record.
- Z-1143-2026 · Oct 24, 2025 · Open, ClassifiedBrand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological pa
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.