Catalog Number 0240060100 |
Device Problem
Loss of Power (1475)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that the sdc shut down in the middle of the case.
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Event Description
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It was reported that the sdc shut down in the middle of the case.
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Manufacturer Narrative
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Alleged failure: shuts down in the middle of cases.The failure alleged in the complaint record was not confirmed or duplicated during the product investigation.The probable root causes can be attributed to system overheating due to lint debris in the interior, or possibly due to issues with the software application, or system drivers.The product was returned for investigation and the failure mode was not confirmed and will be monitored for future reoccurrence.
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Search Alerts/Recalls
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