The (b)(6) physician reported the alleged incident to maquet.The physician did not state that the device failed, or that the device contributed to the incident.The physician informed maquet that they will suspend the use of the adjustable positioning elements (b)(4) on the universal frame (b)(4).The event is under investigation by maquet.A follow-up report will be submitted once additional information is available.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.
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Many different parameters contribute to thrombosis and to thromboembolic events.For example the following parameters are known to have an influence on thromboembolic events in general: duration of the surgical procedure; patient disease; health status of the patient (concomitant morbidity); patient positioning in general (supine position against prone position); weight and age of the patient; prophylactic antithrombotic measures (e.G.Medication, surgical stocking).Thromboembolic events are known to occur in all kinds of surgery without one or several clearly identified risk factor(s).Therefore an informed consent without mentioning that such an event may occur is regarded to be incomplete.However, several tests with the affected adjustable positioning elements 1007.28a0 were performed to determine whether also the device itself could have played a role.Measuring the venous backflow by doppler sonography, performed by two medical experts from outside, of different persons positioned on the adjustable positioning device revealed that the hip elements negatively affect the venous backflow under certain conditions and therefore may be considered as a contributing factor to thromboembolic events.
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