Catalog Number 5100015270 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/02/2017 |
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 event was reported for this quarter; 1 device was received; 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 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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(b)(4).One event was reported for this quarter.One device was received.The reported event was not confirmed for 1 device; the device was found to be within specifications for the reported event.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 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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