Model Number Z6MS TRANSDUCER |
Device Problem
Temperature Problem (3022)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: the complaint was investigated for the acqusition 31 error during exam using z6ms transducer.
The transducer was returned, and an investigation was performed.
Engineers were able to reproduce the acquisition 31 error.
The cause of the issue was determined to be a gastro flex thermistor reliability issue; this is related to design.
Improvements to the gastro flex trace were implemented into forward production, since july 2017.
The transducer returned from the customer site was manufactured prior to the corrective action.
The transducer was replaced at the site by service.
(b)(4).
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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 the patient was sedated, the patient underwent a transesophageal echocardiography (tee) procedure.
During the procedure, the physician was scanning the patients' heart when the transducer generated an over-temperature message.
The physician completed and ended the tee without rebooting the ultrasound system and without replacing the transducer.
There was no loss of data and there was no patient adverse event reported.
No additional information was provided.
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Search Alerts/Recalls
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