117 Cases of CTG-Associated Fetal or Neonatal Deaths from FDA MAUDE

117 adverse event reports involving cardiotocography devices and resulting in death, extracted from the U.S. FDA's MAUDE database. The dataset was compiled by Daniel Kiely and is available via Papers with Code under an Open Access license. The specific time period covered and detailed column information are not provided in the metadata.

Use Cases

• Identify patterns in device-related adverse outcomes based on the 117 reported death events.
• Analyze the relationship between cardiotocography device usage and severe patient outcomes.
• Support regulatory or clinical safety reviews using structured adverse event data from the FDA MAUDE database.

Strengths

• Contains 117 specific cases of a severe outcome (death) linked to medical devices.
• Sourced from the official U.S. FDA MAUDE database, a recognized authority for device adverse events.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment.
• Last update date is unknown; freshness unverified.

Provenance

Source

U.S. FDA MAUDE (Manufacturer and User Facility Device Experience) database

Collection Method

Extraction and compilation of reports involving cardiotocography devices and event type death.

Geography

United States (inferred from data source)