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 03/17/2015 |
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, creating the potential for the device to be activated unintentionally.There was no patient involvement, and there were no user injuries or adverse consequences.
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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, creating the potential for the device to 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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Manufacturer Narrative
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Impact damage is known to cause or contribute to the reported event.The handswitch is not a repairable device and will not be returned to the user facility.
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Search Alerts/Recalls
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