The reported symptom (iipv (dv up to 180% of fv)¿ was not confirmed.The reported symptom ¿electrical shock due to operator error¿ was not confirmed.A visual inspection of the returned cycler exterior showed no signs of physical damage.An (as-received) simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance.Hipot test passed.System air leak test passed.Valve actuation test passed.Patient sensor calibration check passed.Load cell verification was within tolerance.There were no discrepancies encountered during the internal inspection of the cycler.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.
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