Catalog Number 5100015270 |
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 2 events were reported for this quarter.Product return status 1 device was received.1 device investigation type has not yet been determined.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.1 event had no 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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Search Alerts/Recalls
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