Model Number 100724A1 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Muscle Weakness (1967); Nerve Damage (1979)
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Event Type
Injury
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Manufacturer Narrative
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At the time of this report the investigation is still ongoing.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.
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Event Description
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The following was reported.A patient was undergoing a back surgery.For this surgery the adjustable body supports 100728b0 were used on the universal frame, eu 100724a1.On recovering from anesthesia the patient experienced severe weakness of the right upper limb.Clinical evaluation revealed grade 0 motor power of all the muscle groups of the right upper limb.A brachial plexus injury was diagnosed.Manufacturer reference# (b)(4).
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Manufacturer Narrative
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No product failure is apparent which caused the described injury.We have not received any complaints before or after this incident concerning the affected products.We have not received any further information concerning similar incidents from the affected clinic.We assume that the intraoperative positioning of the arms combined with an extended duration of the surgery might have contributed to the described injury.In the instructions for use (ifu) the user is warned concerning the risks related to patient positioning as follows: ¿warning! risk of injury! improper patient positioning may cause health damage (e.G.Decubitus).Position the patient correctly and keep under constant observation.¿ the correct application and positioning of the pads is described in the ifu.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.
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Event Description
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Manufacturer reference#: (b)(4).
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Search Alerts/Recalls
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