Model Number 5100015250 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Burn(s) (1757); 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 12/31/2019 |
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: 13 events were reported for this quarter.Product return status: 1 device was received.12 device investigation types have not yet been determined.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 devices were found to be affected by bearing corrosion.Additional information: 13 devices were not labeled for single-use.13 devices were not reprocessed or reused.
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Event Description
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This report summarizes 13 malfunction events in which the device reportedly overheated.7 events had no patient involvement; no patient impact.1 event had no known patient involvement or patient impact.3 events had patient involvement; no patient impact.2 events had the patient receive a burn.
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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 13 events were originally reported for this failure mode during the reporting quarter.- 1 event was inadvertently excluded.- 14 reported events are included in this follow-up record.Product return status 4 devices were received.10 device investigation types have not yet been determined.Event confirmation status 1 reported event was confirmed.3 reported events were not confirmed.Evaluation results 3 devices were found to be affected by corroded bearings? 1 device was found to be affected by compromised lubrication.
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Event Description
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This report summarizes 14 malfunction events in which the device reportedly overheated.8 events had no patient involvement; no patient impact.1 event had no known impact or consequences to the patient.3 events had patient involvement; no patient impact.2 events had the patient receive a burn.
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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 14 previously reported events are included in this follow-up record.Product return status 6 devices were received.2 devices were not available for evaluation.6 device investigation types have not yet been determined.
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Event Description
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This report summarizes 14 malfunction events in which the device reportedly overheated.- 9 events had no patient involvement; no patient impact.- 1 event had no known impact or consequences to the patient.- 3 events had patient involvement; no patient impact.- 1 event had the patient receive a burn.
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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, h10.14 previously reported events are included in this follow-up record.Product return status 6 devices were received.8 devices were not available for evaluation.
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Event Description
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This report summarizes 14 malfunction events in which the device reportedly overheated.- 7 events had no patient involvement; no patient impact.- 1 event had no known impact or consequences to the patient.- 3 events had patient involvement; no patient impact.- 3 events had the patient receive a burn.
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Search Alerts/Recalls
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