It has come to our attention that medical device manufacturer, TSE spol. s r.o., has initiated a field safety corrective action concerning its neonatal stationary incubator. The affected model numbers are SI-300, SI-301, SI-302 and SI-303.
The manufacturer has recently received an undesirable accident report. A newborn placed in an incubator SI-301 with bed tilted to a maximal position had fallen out through a badly secured left front door during a medical treatment.
During the investigation of the accident, the manufacturer has received information, that the hinge and door function was not properly tested during safety technical inspections of neonatal incubator series SI-300, SI-301, SI-302 and SI-303 (Warranty check, Mechanical part check, step 2.).
This suspicion concerns incubators which were not under direct service supervision of TSE spol. s r.o. engineers. Incubators regularly serviced by TSE spol. s r.o. are risk-free.
Furthermore, the manufacturer advises users to make the proper door function check as soon as possible. Proper door function inspection of incubators not serviced directly by TSE spol. s r.o. will be made by a service technician during an extra inspection. This inspection is covered in regular annual inspections for incubators serviced by TSE spol. s r.o.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 10 January 2013