Maricopa Community Colleges Risks associated with Ventilator splitter Devices Discussion
1. The FDA sends out letters to health care providers detailing issues with devices. Review one of the letters listed below. In 3 paragraphs provide summary of the letter from the FDA. Include the following in your summary
- Device name & use
- SAEs and AEs reported (type and number)
- Common reported problem(s)
- Other complication (if applicable)
2. The FDA also provides recommendations for use to health care providers. Select one of the recommendations from the letter you chose and discuss in 2 paragraphs what the manufacturer could have done during the design, testing, or manufacturing of the device to eliminate the issue.
- SynCardia Systems – TAH-t Companion 2 Driver System (C2) and Risk of Mortality and Stroke – Letter to Health Care Providers (8/17/2018) (Links to an external site.)
- Feeding Tube Placement Systems – Letter to Health Care Providers (1/11/2018) (Links to an external site.)
- Device Failure Associated with Getinge’s Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers (11/1/2018) (Links to an external site.)
- Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers (3/8/2019) (Links to an external site.)
- https://www.fda.gov/medical-devices/letters-health-care-providers/programmable-csf-shunts-and-magnetic-field-interference-implanted-hearing-devices-letter-health-care – Letter to Health Care Providers (7/16/2019) (Links to an external site.)
FDA Letters to Health Care Professionals regarding medical devices can be found at:
https://www.fda.gov/medical-devices/medical-device-safety/letters-health-care-providers
