Model Number 5100015250 |
Device Problem
Overheating of Device (1437)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2019 |
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: 8 events were reported for this quarter.Product return status: 8 device investigation types have not yet been determined.Additional information: 8 devices were not labeled for single-use.8 devices were not reprocessed or reused.
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Event Description
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This report summarizes 8 malfunction events in which the device reportedly overheated.5 events had no patient involvement; no patient impact.2 events had no known impact or consequences to the patient.1 event 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 corrected data: b5, h10 8 events were originally reported for this failure mode during the reporting quarter.9 events should have been reported; 1 event was inadvertently excluded.- 9 reported events are included in this follow-up record.Product return status 1 device was received.2 devices were not available for evaluation.6 device investigation types have not yet been determined.Event confirmation status 1 reported event was confirmed.Evaluation results 1 device was found to be affected by corroded bearings.
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Event Description
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This report summarizes 9 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.2 events had no known impact or consequences to the patient.1 event 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: 9 previously reported events are included in this follow-up record.Product return status: 2 devices were received.5 devices were not available for evaluation.2 device investigation types have not yet been determined.
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Event Description
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This report summarizes 9 malfunction events in which the device reportedly overheated.5 events had no patient involvement; no patient impact.2 events had no known impact or consequences to the patient.2 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 corrected data: h10 9 previously reported events are included in this follow-up record.Product return status 2 devices were received.7 devices were not available for evaluation.
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Event Description
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This report summarizes 9 malfunction events in which the device reportedly overheated.- 5 events had no patient involvement; no patient impact.- 2 events had no known impact or consequences to the patient.- 2 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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