AI-enabled healthcare system developers
Incidents involved as Developer
インシデント 14362 Report
AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During June 2022 Sinus Procedure
2022-06-23
Patient Erin Ralph allegedly suffered carotid-artery injury and a stroke after a June 23, 2022 sinus procedure in Texas in which surgeon Marc Dean reportedly used Acclarent's AI-enabled TruDi Navigation System. Ralph's lawsuit alleged TruDi misinformed Dean about the instrument's position inside her head; Acclarent and Integra LifeSciences, which later acquired Acclarent, reportedly denied a causal connection.
もっとインシデント 15282 Report
AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During May 2023 Sinuplasty
2023-05-19
Patient Donna Fernihough allegedly suffered carotid-artery damage and a same-day stroke during a May 19, 2023 balloon sinuplasty in Texas in which surgeon Marc Dean reportedly used Acclarent's AI-enabled TruDi Navigation System. Her lawsuit alleged the system's AI-assisted navigation contributed to unsafe guidance during the procedure; Acclarent and Integra LifeSciences, which later acquired Acclarent, denied evidence linking TruDi's AI to the injuries.
もっとインシデント 17632 Report
Purportedly AI-Assisted Hospital-Bed Prioritization Allegedly Delayed Intensive Care Before a Patient's Death in Minas Gerais, Brazil
2026-06-06
The family of a 32-year-old patient in Minas Gerais, Brazil, alleged that Core-MG, an AI-assisted hospital-bed allocation system, understated her condition and delayed intensive care. Her sister said the severity score impeded reprioritization. The patient died hours after transfer. The state health department denied a system failure in her case and said physicians assessed patients according to clinical need and bed availability.
もっとインシデント 17541 Report
California Health System Allegedly Used an AI Medical Scribe to Record Patients Without Consent
2025-11-26
A proposed class-action lawsuit alleged that Sharp HealthCare, a California health system, used Abridge, an AI medical scribe, to record patient-clinician conversations without notice or consent and send sensitive audio to the vendor. The documentation workflow allegedly inserted false statements that patients had been informed and consented. Patient Jose Saucedo said he discovered the recording through his medical notes.
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