Model Number 5100004000 |
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 01/01/2021 |
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: 3 events were reported for this quarter.Product return status: 1 device was received.2 device investigation types have not yet been determined.3 devices were not labeled for single-use.3 devices were not reprocessed or reused.
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Event Description
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This report summarizes 3 malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
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Event Description
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This report summarizes 3 malfunction events in which the device reportedly overheated.- 3 events had no patient involvement; no patient impact.
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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, h10 3 previously reported events are included in this follow-up record.Product return status 3 devices were received.
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Search Alerts/Recalls
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