Model Number CS08657-02 |
Device Problem
Smoking (1585)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The information provided indicates that the sample is expected to be returned for analysis.If the sample is returned, a summary of the analysis will be provided in a supplemental report.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received a report from a biomedical engineer where it was initially reported that the unit was dropped and had a damaged front case on the display.The customer called back on the same day and provided information that alleged that the unit started smoking when connected to ac power and a foul odor came from the device.No complication to the end user was reported.
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Manufacturer Narrative
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The customer complaint of faint tones was confirmed.The defective main pcb was replaced.Repair including function testing to test protocol was performed and the unit passed all testing.The unit was reset to standard/ factory settings.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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