Catalog Number 5100015270 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Superficial (First Degree) Burn (2685)
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Event Date 03/02/2018 |
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: nine events were reported for this quarter.Product return status: nine devices were received for evaluation.Evaluation status: seven events were confirmed during testing.-one device was found to be affected a mechanical problem.-five devices were found to be affected by corrosion.-one device was found to be affected by a lubrication problem.One event was not confirmed during testing; the device was found to be within specifications.One device evaluation is in progress. product disposition: this device is not repairable and was not returned to the user facility.Additional information: 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 9 malfunction events in which the device reportedly overheated.Eight events had no patient involvement; no patient impact.One event had patient involvement; the patient received a first-degree 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: 1 previously reported event is included in this follow-up record.Product return status: 1 device was received for evaluation. evaluation status: 1 reported event was not confirmed during testing; however: 1 device was found to be affected by corrosion.1 device is not labeled for single-use.1 device was not reprocessed and reused.
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Event Description
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This report summarizes 9 malfunction events in which the device reportedly overheated.8 events had no patient involvement; no patient impact.1 event had patient involvement; the patient received a first-degree burn.
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Search Alerts/Recalls
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