Catalog Number 403128 |
Device Problems
Leak/Splash (1354); Connection Problem (2900)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/01/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned to the, manufacturer at the time of this report.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation to confirm the alleged defect and determine the root cause.If the device sample becomes available this report will be updated with the evaluation results.
|
|
Event Description
|
Customer complaint alleges "the adaptor for the oxygen outlet is easily dislocated from the aquapak" which is causing leaking.Alleged defect reported as detected during use.There was no report of patient injury.
|
|
Manufacturer Narrative
|
(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.The sample was tested on the dual station lift test and general pull and push test procedures with no functional issues.However, during the setup of the oxygen entrainment test it was observed that the assembly of the nut adaptor and the upper body was unstable.Even with that condition, the sample was able to be tested with no functional issues.As an additional test, the sample was assembled with a sterile water concha mini bottle and tested according to the oxygen entrainment testing.No functional issues were encountered.Based on the investigation performed, the reported complaint could not be confirmed.There were no functional issues found with the returned sample.
|
|
Event Description
|
Customer complaint alleges "the adaptor for the oxygen outlet is easily dislocated from the aquapak" which is causing leaking.Alleged defect reported as detected during use.There was no report of patient injury.
|
|
Search Alerts/Recalls
|