The device referenced in this report was returned to siemens for evaluation.The reported phenomenon of triple image artifacts may have been caused by amb electrical malfunction or coax cable damage.During system test, image dropout was observed.It was found that the mpt2-3 inductor board had detached from the mp connector socket due to insufficient sealant.After inserting mpt2-3 inductor board in the slot and re-assembly, the image dropout disappeared.The possible root cause of the reported phenomenon was insufficient adhesive during manufacturing.As a corrective action, relevant operators have been retrained in the procedure.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.
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During review of service notifications, it was found that the 18l6 hd transducer generated a triple image artifacts during a 2d scanning.According to a patient follow-up report, the customer would have re-initialized the transducer to resolve the issue and complete the intended study.There was no loss of data and there was no patient adverse event reported.No additional information was provided.
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For this complaint, when it was originally received on 09/07/16, it was classified as a non safety issue.A retrospective review for another malfunction was performed to look for all similar reports of a triple image symptom.This complaint was identified as having similarly reported symptoms and therefore it was decided to file an mdr.It was not until the investigation was completed did it become apparent that there were two root causes, one being hardware related and one being software related.The root cause of this specific complaint is related to a failure of the internal hardware components of the transducer and will present with a triplicate image, but the presentation of the image is very obvious to the user and would never be mistaken for one, continuous image.It is hardware related and also has different workflow steps to reproduce the issue compared to the software related failure mode.Based on these findings, this supplemental mdr is to correct the previously submitted reports which did not make this distinction clear.Based on these results, this product malfunction does not lead or have the potential to lead to serious injury or death.
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