Catalog Number 5100009000 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/11/2015 |
Event Type
malfunction
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Event Description
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The universal handswitch was returned for service.Upon evaluation at the manufacturer, it was discovered that the run/safe switch would not lock into either position.When the run/safe switch does not lock, it creates a situation from which the device may be activated unintentionally.There was no patient involvement, and there were no user injuries or adverse consequences.
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Manufacturer Narrative
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The reported event was duplicated.It was confirmed by the service technician through visual inspection the run/safe switch was not locking into place.The device was scrapped by the manufacturer.
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Event Description
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The universal handswitch was returned for service.Upon evaluation at the manufacturer, it was discovered that the run/safe switch would not lock into either position.When the run/safe switch does not lock, it creates a situation from which the device may be activated unintentionally.There was no patient involvement, and there were no user injuries or adverse consequences.
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Manufacturer Narrative
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A follow up report will be filed after the quality investigation has been completed.
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Search Alerts/Recalls
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