|
Model Number 110-0022 |
Device Problems
Pumping Stopped (1503); Suction Problem (2170)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/13/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Field service evaluated the device and determined that the issue was not because of the vacuum pump, but because of the power relay part.The plant evaluation is underway.
|
|
Event Description
|
A user facility reported an issue with the ventx suction pump that resulted in a delay in treatment, while the patient was under general anesthesia.No other information is available but is being sought after.The file will be updated accordingly.
|
|
Manufacturer Narrative
|
Field service was able confirm the issue.It was determined that the issue was due to a power relay part.The pump stopped working after the initial startup.According to the vaserlipo safety risk assessment, insufficient suction issues can cause a delay in the treatment.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.No corrective action is required.
|
|
Search Alerts/Recalls
|
|
|