Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet gmbh, kehler strasse 31, rastatt, germany 76437.Exemption # e2018004.(b)(4), contact person: (b)(6).Initially the customer reported the following malfunction : the end head of the or table moved and the patient slid off the table.A getinge- maquet service tech visited the customer and investigated the device.The described malfunction could not be reproduced.The service tech reported that no one in the room actually saw the table move on its own.After the service tech investigation we assume that the patient was not secured properly on the table.The size of the patient and the angle of the table might have contributed to this event.In the instructions for use (ifu)-the customer is warned that the patient can slip off the table if not secured properly.Quote- ifu " warning! risk of injury! if the patient is not secured during positioning, when adjusting the or table or when positioning the patient (especially when the inclination and /or tilt feature is used), then the patient could slip off the table top in a uncontrolled manner or their legs and legs may hang down.Always secure the patient using suitable aids (e.G.Straps)and maintain continuous observation.And "note if a patient is on the or table: secure the patient prior to moving or adjusting the or table" the service technician inspected the table and found a slight leakage at one of the hydraulic cylinders.This kind of minor leakage could not result in the described malfunction.The leaking cylinder was repaired.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.
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