Catalog Number 5100009000 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/20/2015 |
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 it would not lock in the run or safe 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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(b)(4).The device failed for wear with use over time.The handswitch is not a repairable device and will not be returned to the user facility.
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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 it would not lock in the run or safe 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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Search Alerts/Recalls
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