The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The picture of ecg reading was visually checked and shows ecg readings with minor noises.Twenty-nine (29) electrodes were returned for the investigation.For product analysis, the following tests were performed: ¿ evaluation according to inspection procedure for release control was performed as the results, requirement was fulfilled, all parts existing, nothing has damaged.¿ electrical parameters according to procedure was performed as a result, the requirement was fulfilled.Electrical parameters were within limits.As the samples returned did not show any issues, it is not possible to determine the true root cause.The most probable root cause of the tracing issues could be caused by the used adapters, cables or by impedance limit of the used monitors.A corrective action is not applicable at this time.This complaint will be recorded for tracking and trending purposes.
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