Catalog Number 5100015250 |
Device Problem
Overheating of Device (1437)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 09/01/2018 |
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 - 3 devices were received for evaluation. evaluation status - 3 device evaluations are in progress.Additional information - 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.
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Event Description
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This report summarizes 3 malfunction events in which the device reportedly overheated.1 event had no patient involvement; no patient impact.2 events 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.1 event had no patient involvement; no patient impact.2 events 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 corrected data: h10 3 total events were initially reported.3 previously reported events are included in this follow-up record. product return status 3 devices were received. evaluation status confirmed 1 reported event was confirmed during testing.- 1 device was found to be affected by compromised lubrication.Not confirmed 1 reported event was not confirmed during testing; however: - 1 device was found to be affected by internal corrosion.1 reported event was not confirmed during testing.Additional information 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.
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Search Alerts/Recalls
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