Catalog Number 0986000000 |
Device Problems
Overheating of Device (1437); Sparking (2595)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/13/2014 |
Event Type
malfunction
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Event Description
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It was reported that the cast vacuum is sparking and getting hot during testing at user facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Event Description
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It was reported that the cast vacuum is sparking and getting hot during testing at user facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
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Manufacturer Narrative
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The reported event, sparking and overheating, was confirmed.During the inspection the electrical manufacturing engineer found that the motor is loose in the motor housing causing sparking and heat.Device was repaired and returned to the customer after passing the final inspection.
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Search Alerts/Recalls
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