Catalog Number 6208000000 |
Device Problem
Unintended Power Up (1162)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).1 device was received for evaluation; 1 device evaluation is in progress.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 summarizes1 malfunction event in which the device ran faster than intended.1 event had no patient involvement; no patient impact.
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).One device was received for evaluation; 1 event was duplicated during testing.The device's e-box was replaced.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 1 malfunction event in which the device ran faster than intended.One event had no patient involvement; no patient impact.
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Search Alerts/Recalls
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