(b)(4).A service technician visited the clinic and tried to reproduce the described issue.It was not possible to reproduce it.The stability of the table was checked and found to be ok.No play and no foreign objects under the table base were detected.The ground on which the table was placed was level.Further investigation is still ongoing at the date of this report.Once the investigation is finished, we will provide a follow-up / final report.(b)(4)-maquet provides product failure investigation, analysis and resolution for the device described in this report.
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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, 45 barbour pond drive, wayne, nj 07470, contact person: (b)(4).This issue was further investigated and it was found that or table collided with an instrument table that was blocking the or tables downward movement.The or table top was lowered further and this resulted in the table base of the or table being lifted from the ground.Once the instrument table slipped out or was removed the table base crashed down and injured the doctors foot.In the instructions for use (ifu) the user is warned concerning the risks related to collisions and advised to ensure that the table does not collide with any obstacles when it is adjusted.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.
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