Catalog Number 6207000000 |
Device Problem
Unintended Power Up (1162)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr report is part of the (b)(6), exemption number (b)(4).The reported event was not confirmed for 1 device; the device was found to be within specifications for the reported event.One device is available for evaluation but has not yet been evaluated.There were no remedial actions taken.This device is not labeled for single-use.
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Event Description
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This report summarizes 2 malfunction events in which the device ran in safe mode or the safety of the device did not work, presenting a condition in which the device could be inadvertently activated.There was no patient involvement; no patient impact.
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Manufacturer Narrative
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This mdr report is part of the (b)(6), exemption number (b)(4).One device was received for evaluation.The event was confirmed; an internal component was found to be missing.There were no remedial actions taken.This device is not labeled for single-use.
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Event Description
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This report summarizes 2 malfunction events in which the device ran in safe mode or the safety of the device did not work, presenting a condition in which the device could be inadvertently activated.There was no patient involvement; no patient impact.
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Search Alerts/Recalls
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