Catalog Number 5100004000 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2023 |
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 was not available for evaluation.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 had patient involvement; no patient impact.
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Search Alerts/Recalls
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