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Neo-Tee Resuscitators are used for emergency breathing support for neonates and infants. The inline controller may come apart and impact ventilation.
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Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers
The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy.
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FDA Roundup: October 4, 2024
FDA Roundup: October 4, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-october-4-2024
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IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug
IPV Phasitron 5 In-Line Valve helps provide therapy to promote ventilation. Users need to remove the expiratory port plug before direct ventilation.
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FDA Roundup: October 1, 2024
FDA Roundup: October 1, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-october-1-2024
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FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect
FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect
http://www.fda.gov/news-events/press-announcements/fdas-unified-human-foods-program-new-model-field-operations-and-other-modernization-efforts-go
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Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy
Ivenix LVP allows for controlled administration of large volumes of fluids but software anomalies may lead to delay or underdosing of therapy.
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Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation
Trilogy Evo, EV300, EvoO2 and Evo Universal ventilators support patient breathing. A mandatory software correction was issued to address previously reported issues.
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Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement
paraPAC Plus P300 and P310 Ventilators are gas-powered emergency and transport portable ventilators. The tidal volume knob may move out of the set position.
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FDA Roundup: September 27, 2024
FDA Roundup: September 27, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-27-2024