Model Number 5100004000 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/30/2019 |
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: 5 events were reported for this quarter.Product return status: 5 device investigation types have not yet been determined.Additional information: 5 devices were not labeled for single-use.5 devices were not reprocessed or reused.
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Event Description
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This report summarizes 5 malfunction events in which the device reportedly overheated.5 events had no 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: h10 5 previously reported events are included in this follow-up record.Product return status 1 device was received.4 device investigation types have not yet been determined.Event confirmation status 1 reported event was confirmed.Evaluation results 1 device did not have a root cause established.
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Event Description
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This report summarizes 5 malfunction events in which the device reportedly overheated.5 events had no 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: b5, h10 5 events were previously reported during the reporting quarter; however: - 2 events were reported in error.- 3 previously reported events are included in this follow-up record.Product return status 1 device was received.1 device was not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status 1 reported event was confirmed.Evaluation results 1 device was found to be affected by an overheated cable.
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Event Description
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This report summarizes 3 malfunction events in which the device reportedly overheated.3 events had no 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: h10 3 previously reported events are included in this follow-up record.Product return status 1 device was received.2 devices were not available for evaluation.Event confirmation status 1 reported event was confirmed.Evaluation results 1 device was found to be affected by an overheated cable.
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Event Description
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This report summarizes 3 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.
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Search Alerts/Recalls
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