Catalog Number 5100015252 |
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 03/31/2024 |
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 (b)(4) event was reported for this quarter.Product return status (b)(4) device was not available for evaluation.Additional information (b)(4) device was not labeled for single-use.(b)(4) device was not reprocessed or reused.H3 other text : device discarded.
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Event Description
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This report summarizes (b)(4) malfunction event in which the device reportedly overheated.- (b)(4) event had no patient involvement; no patient impact.
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Search Alerts/Recalls
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