FDAFDA · Alimentos y medicamentos·N.º oficial Z-0926-2014
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
Publicado el 12 de febrero de 2014 · Inicio del retiro: 11 de septiembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- ArjoHuntleigh Inc.
- Distribuidor
- US Nationwide and Middle East
- Lote
- Model #209500
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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