This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 12 events were reported for this quarter.Product return status: 12 devices were received.Event confirmation status: 12 reported events were not confirmed.Evaluation results: 3 devices were found to be affected by high impedance.9 devices had no problem found.Additional information: 12 devices were not labeled for single-use.12 devices were not reprocessed or reused.
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