Catalog Number 5407FA2000 |
Device Problem
Overheating of Device (1437)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/31/2024 |
Event Type
malfunction
|
Event Description
|
This report summarizes 58 malfunction events in which the device reportedly overheated.47 events had no patient involvement; no patient impact.11 events had patient involvement; no patient impact.
|
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 58 events were reported for this quarter.Product return status: 58 devices were evaluated based on historical data analysis.Additional information: 58 devices were not labeled for single-use.58 devices were not reprocessed or reused.
|
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale : 58 events were originally reported for this failure mode during the reporting quarter; however, 1 event was inadvertently excluded.59 reported events are included in this follow-up record.Product return status: 59 devices were evaluated based on historical data analysis.
|
|
Event Description
|
This report summarizes 59 malfunction events in which the device reportedly overheated.48 events had no patient involvement; no patient impact.11 events had patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|