It was reported that a case of compartment syndrome occurred.The patient was treated on an alphamaxx table.Further information concerning patient data, performed surgery, used product(s) and malfunction were asked, but not yet provided when this report was created.Manufacturer reference: (b)(4).
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The customer reported that a compartment syndrome occurred during surgery with a getinge-maquet product.A getinge-maquet field service engingeer has visited the clinic and investigated the products in question.He confirmed that no damage or malfunction could be found on the or table or attached accessories.Furhter information concerning patient data (age, weight, height, preexisting medical conditions), performed surgery and patient outcome was requested from the hospital.The hospital refused to provide this information due to protection of personal information.A compartment syndrome can be caused due to different influences ( patient position, operating time, lithotomy position, ankle above heart level, strong lower leg and / or high bmi, intraoperative compression of the large vessels, a history of cardiovascular issues).Since no product malfunction was found, we assume that in this case several unfavorable factors came together and thus led to the described injury.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.
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