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 09/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: the complaint was investigated for a temperature problem the the z6ms probe.
The transducer was returned, and an investigation was performed.
Engineers were able to reproduce an aquisition 31 error.
The cause was determined to be articulation sleeve reliability issue.
A c-flex articulation sleeve material inspection & rework process was implemented since novevmber 2015.
And a new sleeve material change was implemented since septebmer 2016.
This transducer was prior to the corrective action.
The transducer was replaced at the site.
(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 while the patient was in the middle of undergoing a transesophageal echocardiography (tee) procedure, a temperature issue occurred soon after the transducer was connected to the ultrasound system.
The physician rebooted the ultrasound system and the functionality was restored.
The tee was continued and subsequently completed without replacing the transducer.
The delay was only when the system was rebooted.
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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