Model Number WIDE / FLAT |
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 09/30/2022 |
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: 1 event was reported for this quarter.Product return status: 1 device was not available for evaluation.Additional information: 1 device was labeled for single-use.1 device was reprocessed or reused.
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Event Description
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This report summarizes 1 malfunction event in which the device reportedly overheated.1 event had patient involvement; no patient impact.
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Event Description
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This report summarizes: 1 malfunction event.In which, the device reportedly overheated.1 event, had patient involvement.No patient impact.
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Manufacturer Narrative
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Additional information: 1 device was not reprocessed or reused.
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Search Alerts/Recalls
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