This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.
Reported events: 5 events were reported for this quarter.
Product return status: 5 devices were received.
Event confirmation status: 4 reported events were confirmed; the cause traced to component failure.
1 reported event was not confirmed.
Evaluation results: 4 devices were found to be affected by nose tip disassembly.
1 device was found to be affected by nose tip disassembly and missing components.
Additional information: 5 devices were not labeled for single-use.
5 devices were not reprocessed and reused.
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