Model Number Z6MS TRANSDUCER |
Device Problems
Device Displays Incorrect Message (2591); Temperature Problem (3022)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: the complaint was investigated for z6ms probe causes acquisition error 31.
The transducer was returned, and an investigation was performed.
Engineers were able to reproduce an acquisition 31 error.
The cause of the issue was determined to be a gastro flex thermistor trace fault because of gastro flex reliability; 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.
(b)(4).
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Event Description
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It was reported that during equipment testing and prior to the start of a transesophageal echocardiography (tee) procedure, the transducer generated a usacquisition_hw_31 overtemperature error.
The user rebooted the ultrasound system to restore functionality.
The planned tee procedure was subsequently performed and completed with a different transducer.
There was no patient adverse event reported.
No additional information was provided.
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Search Alerts/Recalls
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