It was reported that a patient was positioned on the operating room table column 116001a0, serial number (b)(4) in combination with the table top 115016b0, serial number (b)(4).The patient was positioned for an x ray.The table top was tilted by 28°.The patient slid off the table top and died three days later.Manufacturer reference # (b)(4).
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A getinge - maquet service technician was informed on 2019-03-15 by someone from the neurosurgery department of the clinic that a patient was positioned on a 115016b0 table top.The patient should get an x-ray.For this purpose, the table top was tilted laterally.In the course of this position change the patient fell off the table top.It was also reported that the patient died 3 days after the incident.The clinic was contacted several times by e-mail and telephone to obtain further information on the incident described.Feedback / information from the clinic: on 2019-03-15 getinge - maquet service technician was informed by the clinic's neurosurgery department about an incident.The name of the person who provided the information to getinge - maquet is not known.On 2019-03-18 contact with the clinic's biomedical engineering department.The incident is not known at the clinic.On 2019-04-24 again contact with the biomedical engineering department: information received that the clinic also doesn¿t know who informed getinge - maquet.The incident is not known in the clinic.The mentioned product is still in clinical use, there is no product defect.The product in question was manufactured on 2017-12.The dhr of the product in question was inspected, no deviations were found.Results of the dhr review of production order: no issues relating the complaint indicated.Review of inspection reports: no issues relating the complaint indicated.Review of used labels: no issues relating the complaint indicated.Review of internal error reports: no internal error reports existent.Review of concessions: no permissions for concessions regarding this product existent.Review, if the product was already claimed regarding this issue: no indications.With the information available, we assume that there was a misinformation.The described incident is not known at the clinic.We have been informed that the mentioned product works perfectly and that no malfunction has occurred.Whoever passed the information on to getinge - maquet cannot be traced afterwards.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.(b)(4) (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.(b)(4).
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