Model Number 6701132 |
Device Problems
Device Alarm System (1012); No Audible Alarm (1019); Suction Failure (4039)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/05/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow up report will be filed once the results have been completed.
|
|
Event Description
|
The nurse called after hours with concerns about one of their devices not alarming properly.She can clamp the tubing for over 30 minutes and the canister full/blockage alarm will not go off.She also said the low pressure/leak alarm does not go off even when the dressing is not suctioned down.
|
|
Manufacturer Narrative
|
Supplemental report being files since investigation has been completed.Complaint sample not received for investigation.Device history record showed no issues.Device, serial # (b)(6), released from qa to stock on 01/15/2020 and passed all tests.
|
|
Search Alerts/Recalls
|