Model Number 5100015250 |
Device Problems
Corroded (1131); Overheating of Device (1437)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2020 |
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: 6 events were reported for this quarter.Product return status: 1 device was received.5 device investigation types have not yet been determined.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 device was found to be affected by a corroded bearing.Additional information: 6 devices were not labeled for single-use.6 devices were not reprocessed or reused.
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Event Description
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This report summarizes 6 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.
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Event Description
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This report summarizes 6 malfunction events in which the device corroded and reportedly overheated.- 6 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: h10 6 previously reported events are included in this follow-up record.Product return status 6 devices were received.
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Search Alerts/Recalls
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