Model Number 1900034000 |
Device Problem
Overheating of Device (1437)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2020 |
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: 12 events were reported for this quarter.Product return status: 6 devices were received.6 device investigation types have not yet been determined.Event confirmation status: 5 reported events were confirmed.1 reported event was not confirmed.Evaluation results: 4 devices were found to be affected by a damaged bearing.1 device was found to be affected by a damaged rotor.1 device had no problem found.12 devices were not labeled for single-use.12 devices were not reprocessed or reused.
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Event Description
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This report summarizes 12 malfunction events in which the device reportedly overheated.11 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
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Event Description
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This report summarizes 12 malfunction events in which the device reportedly overheated.- 7 events had no patient involvement; no patient impact.- 5 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: 12 previously reported events are included in this follow-up record.Product return status: 9 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status: 5 reported events were confirmed.4 reported events were not confirmed.Evaluation results: 4 devices were found to be affected by a damaged bearing.1 device was found to be affected by a damaged rotor.4 devices had no problem found.
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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 12 previously reported events are included in this follow-up record.Product return status 9 devices were received.3 devices were not available for evaluation.
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Event Description
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This report summarizes 12 malfunction events in which the device reportedly overheated.- 7 events had no patient involvement; no patient impact.- 5 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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