Catalog Number 5100015270 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2019 |
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: 10 events were reported for this quarter. product return status: 9 devices were received.1 device was not available for evaluation. event confirmation status: 2 reported events were confirmed; the cause traced to component failure.6 reported events were not confirmed.1 device evaluation is still in progress.Evaluation results: 2 devices were found to be affected by internal component corrosion.1 device was found to be affected by worn internal components.1 device was found to be affected by lubrication breakdown.2 devices were found to be affected by debris.1 device was found to be affected by internal component corrosion and debris.1 device had no device problem found. additional information: 10 devices were not labeled for single-use.10 devices were not reprocessed and reused.
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Event Description
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This report summarizes 10 malfunction events in which the device reportedly overheated.9 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
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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: 10 previously reported events are included in this follow-up record.Product return status 9 devices were received.1 device was not available for evaluation.Event confirmation status 2 reported events were confirmed.7 reported events were not confirmed.Evaluation results 2 devices were found to be affected by internal component corrosion.2 devices were found to be affected by internal lubrication breakdown.2 devices were found to be affected by internal debris.1 device was found to be affected by internal corrosion and debris.1 device was found to be affected by worn internal components.1 device had no problem found.
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Event Description
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This report summarizes 10 malfunction events in which the device reportedly overheated.9 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
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Search Alerts/Recalls
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