Catalog Number 5100015250 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Burn, Thermal (2530)
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Event Date 12/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 20 events were reported for this quarter. product return status: 17 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined. evaluation status: confirmed.10 reported events were confirmed during testing.4 devices were found to be affected by corrosion.1 device was found to be affected by shattered bearings.2 devices were found to be affected by corrosion and debris.2 devices were found to be affected by lubrication breakdown.1 device was found to be affected corrosion, debris, and shattered bearings.Not confirmed: 5 reported events were not confirmed during testing; however: 2 devices were found to be affected by corrosion.1 device was found to be affected by corrosion and debris.1 device was found to be affected by debris.1 device was found to be affected by shattered bearings.1 reported event was not confirmed during testing.In progress: 1 device evaluations are in progress.Additional information: 20 devices were not labeled for single-use.20 devices were not reprocessed and reused.
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Event Description
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This report summarizes 20 malfunction events in which the device reportedly overheated.18 events had no patient involvement; no patient impact.1 event had 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 20 malfunction events in which the device reportedly overheated.18 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.1 event had the patient receive a burn.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: 20 previously reported events are included in this follow-up record.Product return status 17 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status 10 reported events were confirmed; the cause was traced to component failure.7 reported events were not confirmed.Evaluation results 6 devices were found to be affected by corrosion.2 devices were found to be affected by lubrication breakdown.3 device was found to be affected by corrosion and debris.2 device was found to be affected by and debris.2 devices were found to be affected by shattered bearings.1 device was found to be affected corrosion, debris, and shattered bearings.1 device had no problem found.
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Search Alerts/Recalls
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