On Feb. 6, the FDA issued a recall for High Frequency Transport Phasitron Breathing Circuit Kit (A50605-D). The High Frequency Transport Phasitron Breathing Circuit Kit is used for continuous ventilation of patients. The kit is intended to be used with Percussionaire high frequency percussive ventilation (HFPV) systems for either hospital or prehospital use where emergency care is being provided. The kit can also be used for transport within a hospital or outside a hospital.
Percussionaire is recalling their High Frequency Transport Phasitron Breathing Circuit Kits due to a product defect that causes over-pressurization. There are two parts of the Phasitron kit that must be pressed together during manufacturing. If one part is angled incorrectly and pressed, the part can become deformed. This causes the PEEP (positive end expiratory pressure) valve to be stuck in the closed position. When the valve is stuck, there is no way to manually release the valve.
The use of the affected Phasitron kits may cause serious adverse health consequences, including lung injury, low blood pressure, collapsed lung, cardiac arrest, and death.
There have been three complaints regarding this device issue, and one injury. There have been no reports of death.
FDA has the recall.