Model Number SPL-S |
Device Problems
Defective Component (2292); Material Twisted/Bent (2981)
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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 was evaluated.Inspection of the device found damaged transducer receptacle with broken pins.Minor scratches on the housing and front determined.The identified parts were replace, device was repaired.Once completed the device was tested and passed all required testing and specifications.Reported issue was confirmed.Probable cause could be due to maintenance and or handling issue.If additional information becomes available this report will be supplemented accordingly following the investigation.
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Event Description
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It was reported that during preparation for use the device was found with broken transducer receptacle.Bent pins were found inside the 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 supplemental report is to advise 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.
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Search Alerts/Recalls
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