Device evaluated by manufacturer and h6.Health impact, and evaluation codes: updated.One device was received in used condition without the original packaging.Visual inspection detected that the cuff had damage (tear).A leak test was performed to confirm the defect in the sample, the sample failed the test confirming the complaint and a root cause was due to improper use of the product.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
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