Evaluation of Adverse Events Recorded in FDA/USA and ANVISA/Brazil Databases for the Medical Equipment: Pulmonary Ventilators, Defibrillators, Infusion Pumps, Physiological Monitors and Ultrasonic Scalpels

Author:

de Souza Josiany Carlos,Mehrpour Sheida,Ferreira Matheus Modolo,Coelho Y. L.,Vivas G. C.,Delisle-Rodriguez D.,Santos Francisco de Assis,Bastos-Filho T. F.

Publisher

Springer International Publishing

Reference25 articles.

1. ANVISA. RDC number 02 (2010) Gerenciamento de tecnologias em saúde em estabelecimentos de saúde

2. Gao X et al (2019) A hazard analysis of class I recalls of infusion pumps. JMIR Hum Fctors. https://doi.org/10.2196/10366

3. Data Mining at the Center for Devices and Radiological Health at https://www.fda.gov/science-research/data-mining/data-mining-center-devices-and-radiological-health

4. Medical Device Reporting (MDR): How to Report Medical Device Problems at https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

5. OpenFDA at https://www.fda.gov/science-research/health-informatics-fda/openfda

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