Model Number 8205000000 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
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: 2 events were reported for this quarter.Product return status: 2 device investigation types have not yet been determined.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
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Event Description
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This report summarizes 2 malfunction events in which the device operated in the wrong mode.2 events had no patient involvement; no patient impact.
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Event Description
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This report summarizes 1 malfunction event in which the device operated in the wrong mode.1 event 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: 2 events were previously reported during the reporting quarter; however, 1 event was reported in error.1 previously reported event is included in this follow-up record.Product return status 1 device was received.
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Search Alerts/Recalls
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