MADRID, 21 (EUROPA PRESS)
The Spanish Agency for Medicines and Health Products (AEMPS) warned this Thursday about the risk of air leaks in the pneumatic cells of the Axtair Automorpho Plus and Axtair One Plus motorized air mattresses, which can cause the mattress to deflate.
These mattresses are intended to prevent and assist in the treatment of established pressure ulcers, from stages 1 to 4, for patients who are up or not during the day, or who present a medium to very high risk of suffering from ulcers, so their deflation could aggravate pressure injuries, generate instability with risk of falls, injury, pain and skin damage due to high pressures on the support points.
The affected products are those with pneumatic cells with lot numbers F2212236A or F2303333A, according to information provided by the Valencian company Winncare, responsible for their distribution in the country, which has already sent a warning note to orthopedic clinics and patients informing them of the problem detected and the actions to be taken.
The affected Axtair Automorpho Plus items are those with lot numbers 2321, 2330, 2339, 2322, 2331, 2340, 2323, 2332, 2341, 2324, 2333, 2342, 2325, 2334, 2343, 2326, 2335, 2344, 2327, 2336, 2345, 2328, 2337, 2346, 2329 and 2338.
In the case of Axtair One Plus, they are those with lot number 2321, 2330, 2339, 2322, 2331, 2340, 2323, 2332, 2341, 2324, 2333, 2342, 2325, 2334, 2343, 2326, 2335, 2344, 2327, 2336, 2345, 2328, 2337, 2346, 2329 and 2338.
If the cells comprising the pneumatic assembly of the motorized air mattress are defective, an air leak could occur, triggering an audible and visual alarm. If the compressor cannot compensate for the leak, another audible and visual alarm would sound, and inflation would stop to prevent the pump from overheating.
Patients who have one of these mattresses should check the batch number of each automatic cell and, if it matches, contact the manufacturer's authorized technical service at sat@winncare.es to have it replaced.
If an audible or visual alarm is heard, or if pressure loss persists, or if the mattress cannot maintain therapeutic pressure, the patient should discontinue use and contact the manufacturer's authorized service center.
Orthopedic clinics, for their part, must identify whether they have sold any of these mattresses and, if so, must read the warning notice and communicate the information contained therein to patients.
