Model Number Z6MS TRANSDUCER |
Device Problems
Overheating of Device (1437); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This issue is under investigation.A follow-up report will be submitted when the investigation results are available.
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Event Description
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It was reported that the system displayed a usacquisitionhw_31 error message, an indication that the transducer is overheating.The reported phenomenon occurred during a 3d transesophageal echocardiography (tee) study.Since the system exhibited the error message sporadically, the user was able to complete the tee with the same transducer.There was no loss of data so the study was not repeated.The study was prolonged only by ten minutes but there was no patient or user injury reported.No additional information was provided.
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Manufacturer Narrative
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The device referenced in this report was returned to siemens for evaluation.During visual inspection, there was no physical damage noted on the articulation sleeve area.The device was functionally tested and the temperature monitoring error (usacquisitionhw_31 error) was able to be reproduced.During destructive analysis, it was found an open micro crack on the gastro flex # 7.The possible root cause of the reported phenomenon was caused by electrical trace micro crack due to insufficient reliability.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.(b)(4).
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Search Alerts/Recalls
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