Model Number 5407-120-472 |
Device Problems
Overheating of Device (1437); Detachment of Device or Device Component (2907)
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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 investigation type has not yet been determined.Additional information 1 device was not 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 reported overheated and disassembled.- 1 event had 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: 1 previously reported event is included in this follow-up record.Product return status: 1 device was received.Additional information: 1 device was not reprocessed or reused.
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Event Description
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This report summarizes 1 malfunction event in which the device reported overheated and disassembled.1 event had patient involvement; no patient impact.
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Search Alerts/Recalls
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