Catalog Number 5100015250 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2023 |
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 14 events were reported for this quarter.Product return status 8 devices were received.2 devices were not available for evaluation.4 device investigation types have not yet been determined.Additional information 14 devices were not labeled for single-use.14 devices were not reprocessed or reused.
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Event Description
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This report summarizes 14 malfunction events in which the device reportedly overheated.- 9 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.- 2 events 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: b5, h6, h10 14 previously reported events are included in this follow-up record.Product return status 8 devices were received.4 devices were not available for evaluation.2 device investigation types have not yet been determined.
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Event Description
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This report summarizes 14 malfunction events in which the device reportedly overheated.- 9 events had no patient involvement; no patient impact.- 4 events had patient involvement; no patient impact.- 1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
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Event Description
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This report summarizes 14 malfunction events in which the device reportedly overheated.9 events had no patient involvement; no patient impact.4 events had patient involvement; no patient impact.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: 14 previously reported events are included in this follow-up record.Product return status: 8 devices were received.6 devices were not available for evaluation.
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Search Alerts/Recalls
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