The affected product was manufactured in 2006.The following malfunction was reported: the attached shoulder plate gave way during use when someone bumped against it.The shoulder plate is locked at the table interface via two toothed discs which are pre-loaded via rubber buffers.A getinge-maquet gmbh service technician visited the clinic and investigated the product in question.All toothed discs and rubber buffers have been replaced.The described issue could be caused by work out tooth discs and/or rubber buffers, or the connection was not properly secured by the customer, or the connection was loosened unnoticed during the procedure, or the connection gave way due to overload, or an unfortunate combination of the described situations.In the instructions for use (ifu) it is stated that getinge-maquet products may used only when fully functional.Further it is stated that the devices have to be checked/inspected for functional and mechanical integrity before utilization.In this case the exact root cause could not be identified.We assume that a combination of slightly worn parts in combination with overload and/or a not properly secured connection caused the described issue.Getinge-maquet gmbh provides product failure investigation, analysis, and resolution for the device described in this report.Getinge usa sales, llc (importer) is submitting this report on behalf of of the legal manufacturer of the device maquet gmbh, kehler strasse 31, rastatt, germany 76437.Exemption # e2018004 getinge usa sales, llc (b)(6).
|