Catalog Number 5100015250 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2019 |
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: 15 events were reported for this quarter.
Product return status: 11 devices were received.
1 device was not available for evaluation.
3 device investigation types have not yet been determined.
event confirmation status: 5 reported events were confirmed; the cause traced to component failure.
5 reported events were not confirmed.
1 device evaluation is still in progress.
Evaluation results: 4 devices were found to be affected by internal component corrosion.
2 devices were found to be affected by worn internal components.
1 device was found to be affected by lubrication breakdown.
3 devices were found to be affected by components covered in debris.
1 device was found to be affected by shattered bearings.
Additional information: 15 devices were not labeled for single-use.
15 devices were not reprocessed and reused.
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Event Description
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This report summarizes 15 malfunction events in which the device reportedly overheated.
12 events had no patient involvement; no patient impact.
1 event had patient involvement; no patient impact.
2 events had the patient receive a burn.
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Search Alerts/Recalls
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