H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of the unit is giving ec303 error code was confirmed.When plugging in a sensor, it displays a ec303 error code.This is due to the sensor being close to the probe.The sensor should be couple feet away from the probe and it will work fine.The root cause of the reported issue is sensor is too close to the 20mm gt probe.A history review of serial number dyaqac026 showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.
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