Model Number Z6MS TRANSDUCER |
Device Problem
Signal Artifact/Noise (1036)
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Patient Problems
No Consequences Or Impact To Patient (2199); Sedation (2368)
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Event Date 07/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device referenced in this report has not been returned to siemens for evaluation.If additional information is received or if the device is returned at a later date, this report will be supplemented.
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Event Description
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It was reported that after given light anesthesia, the patient underwent a 2d and 4d transesophageal echocardiography (tee) procedure.During patient scanning in b-mode when the color dopler was activated, the user observed colored artifact on the image.The user rebooted the ultrasound system but did not remove the transducer.When the artifact disappeared, the user continued and completed the tee.There was a 10-minute delay in completing the procedure.There was no patient adverse event reported.No additional information was provided.
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Manufacturer Narrative
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Investigation: the complaint was investigated for color artifact in z6ms images.The transducer was returned, and an investigation was performed.It was found that the cause of the image artifacts on the transducer was coaxial cable manufacturing issue, which is being addressed through a capa.This transducer was manufactured prior to the corrective action.(b)(4).
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Search Alerts/Recalls
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