Model Number 1900015000 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/31/2019 |
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: 2 events were reported for this quarter.Product return status: 1 device was evaluated in the field.1 device investigation type has not yet been determined.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 device had no problem found.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
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Event Description
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This report summarizes 2 malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.
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Event Description
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This report summarizes 2 malfunction events in which the device reportedly overheated.2 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 2 previously reported events are included in this follow-up record.Product return status: 2 devices were received.Event confirmation status: 2 reported events were not confirmed.Evaluation results: 1 device was found to be affected by gritty bearings.1 device had no problem found.
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Search Alerts/Recalls
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