Model Number 5100015250 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2023 |
Event Type
malfunction
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Event Description
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This report summarizes 10 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.4 events had patient involvement; no patient impact.1 event had insufficient information received.1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
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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 6 devices were received.1 device was not available for evaluation.3 device investigation types have not yet been determined.Additional information 10 devices were not labeled for single-use.10 devices were not reprocessed or reused.
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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: 10 previously reported events are included in this follow-up record.Product return status 8 devices were received.1 device was not available for evaluation.1 device investigation type has not yet been determined.
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Event Description
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This report summarizes 10 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.4 events had patient involvement; no patient impact.1 event had insufficient information received.1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
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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: h6, h10 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.
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Event Description
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This report summarizes 10 malfunction events in which the device reportedly overheated.- 4 events had no patient involvement; no patient impact.- 4 events had patient involvement; no patient impact.- 1 event had insufficient information received.- 1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
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Search Alerts/Recalls
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