Model Number 8208000000 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
|
Event Date 09/30/2019 |
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: 4 events were reported for this quarter.Product return status: 2 devices were not available for evaluation.2 device investigation types have not yet been determined.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed or reused.
|
|
Event Description
|
This report summarizes 4 malfunction events in which the device was reportedly leaking.3 events 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 4 previously reported events are included in this follow-up record.Product return status 4 devices were not available for evaluation.
|
|
Event Description
|
This report summarizes 4 malfunction events in which the device was reportedly leaking.3 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|