Model Number 5407-120-450 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/30/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
This report summarizes 2 malfunction events in which the device had a component detach.2 events had no patient involvement; no patient impact.
|
|
Event Description
|
This report summarizes 3 malfunction events in which the device had a component detach.3 events had no 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.Supplemental rationale: 2 events were originally reported for this failure mode during the reporting quarter; however, 1 event was inadvertently excluded.3 reported events are included in this follow-up record.Product return status 2 devices were received.1 device investigation type has not yet been determined.
|
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10.3 previously reported events are included in this follow-up record.Product return status 2 devices were received.1 device was not available for evaluation.
|
|
Event Description
|
This report summarizes 3 malfunction events in which the device had a component detach.- 3 events had no patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|