The microsensor was returned for evaluation.Device history record (dhr) - the product code 82-6631 with lot 3943128 conformed to the specifications when released to stock.Failure analysis - the issue of the complaint was not confirmed: no visible damage to the millar sensor, catheter material, or connector.The icp express reading passed with 549.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.The root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause of the defect reported by the customer could be due to excessive pressure applied to product.
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