Catalog Number 5100004000 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Burn, Thermal (2530); No Patient Involvement (2645); No Patient Involvement (2645)
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Event Date 06/02/2018 |
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). reported events - 2 events were reported for this quarter.Product return status - 2 devices were received for evaluation.Evaluation status - 1 event was not confirmed during testing; however, - 1 device was found to be affected by a failed electrical component.1 device evaluation is in progress.Additional information - the device was not labeled for single-use.The device was not reprocessed and reused.
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Event Description
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This report summarizes 2 malfunction events in which the device reportedly overheated.1 event had no patient involvement; no patient impact.1 event had the patient receive a burn.
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Event Description
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This report summarizes 2 malfunction events in which the device reportedly overheated.1 event had no patient involvement; no patient impact.1 event had the patient receive a burn.
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale corrected data: 2 total events were initially reported.1 previously reported event is included in this follow-up record.Product return status 1 device was not available for evaluation.Additional information 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.H3 other text : device not returned.
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Search Alerts/Recalls
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