Catalog Number 5100131000 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).One event was reported for this quarter.One device was received.One 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 summarizes 1 malfunction event in which the device reportedly overheated.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 malfunction summary reporting program, exemption number e2015055.1 device was received.The reported event was not duplicated during testing for 1 device; however, the device was outside specifications.1 device was found to be affected by worn components.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 reportedly overheated.There was no patient involvement; no patient impact.
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Search Alerts/Recalls
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