Model Number SPL-S |
Device Problem
Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device inspection observed with power output out of specifications due to faulty burnt transducer.Minor scratches on the housing was noted.The identified parts were replaced and device was repaired.Once completed the device was tested and passed required testing and specifications.Based on evaluation findings the reported issue was found to be due to burnt faulty transducer attributed to electronic failure.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Event Description
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It was reported that during an annual asset inspection the device was observed with power output out of specifications due to faulty transducer.There was no patient involvement on this event reported.No user injury reported.
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Manufacturer Narrative
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This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.The following sections were updated: g4, g7, h2 and h10.
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Search Alerts/Recalls
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