Catalog Number 5400210057 |
Device Problem
Bent (1059)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Three events were reported for this quarter.Three devices were received for evaluation; two events were confirmed during testing.Two devices were found to be bent.One device evaluation is in progress.This device is not repairable and was not returned to the user facility.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 3 malfunction events in which the device was bent.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 for evaluation; 1 event was confirmed during testing.1 device was found to be bent.This device is not repairable and was not returned to the user facility.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 3 malfunction events in which the device was bent.There was no patient involvement; no patient impact.
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Search Alerts/Recalls
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