Model Number 3650 |
Device Problems
Overheating of Device (1437); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported a programmer started to smoke during a case.The use of the programmer was discontinued for that case.In an effort to further investigate the status of the programmer, the next day it was determined the programmer was dim and hard to use.The programmer will be returned and replaced.
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Manufacturer Narrative
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Final analysis found burn marks on the inverter printed circuit board assembly from an overheated transformer which resulted in the dim display panel.Additional findings: no conclusion code available.Failure event observed during analysis.Final analysis found broken printer hinges which prevented the print head from closing causing print out anomalies.Physical damage was the cause of these print out anomalies.
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Search Alerts/Recalls
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