Catalog Number 5100015270 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Burn, Thermal (2530)
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Event Date 06/24/2019 |
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: 4 events were reported for this quarter.Product return status: 1 device was not available for evaluation.3 device investigation type has not yet been determined.4 devices were not labeled for single-use.4 devices were not reprocessed and reused.
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Event Description
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This report summarizes 4 malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.2 events 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: 4 previously reported events are included in this follow-up record.Product return status: 2 devices were received.2 devices were not available for evaluation.Event confirmation status: 1 reported event was confirmed.1 reported event was not confirmed.Evaluation results: 1 device was found to be affected by lubrication breakdown.1 device had no problem found.
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Event Description
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This report summarizes noe 4 /noe malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.2 events had the patient receive a burn.
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Search Alerts/Recalls
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