Model Number 5100004000 |
Device Problem
Overheating of Device (1437)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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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: 4 events were reported for this quarter.Product return status: 4 device investigation types have not yet been determined.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed or reused.
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Event Description
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This report summarizes 4 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.
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Event Description
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This report summarizes 4 malfunction events in which the device reportedly overheated.4 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 4 previously reported events are included in this follow-up record.Product return status 1 device was received.3 device investigation types have not yet been determined.Event confirmation status 1 reported event was not confirmed.Evaluation results 1 device had no problem found.
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Event Description
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This report summarizes 4 malfunction events in which the device reportedly overheated.4 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: 4 previously reported events are included in this follow-up record.Product return status: 1 device was received.3 devices were not available for evaluation.
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Search Alerts/Recalls
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