Model Number 8205000000 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/30/2020 |
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 was reportedly leaking.2 events had insufficient information received.
|
|
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: b5, h10.2 previously reported events are included in this follow-up record.Product return status: 1 device was received.1 device investigation type has not yet been determined.
|
|
Event Description
|
This report summarizes 2 malfunction events in which the device was reportedly leaking.1 event had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
|
|
Event Description
|
This report summarizes 2 malfunction events in which the device was reportedly leaking.- 1 event had no patient involvement; no patient impact.- 1 event 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.Supplemental rationale corrected data: h10 2 previously reported events are included in this follow-up record.Product return status 1 device was received.1 device was not available for evaluation.
|
|
Search Alerts/Recalls
|