Catalog Number 031-33J |
Device Problem
No Flow (2991)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
|
Event Date 06/14/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn#(b)(4).A visual, dimensional and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided.However samples of code 031-33j batch 74f1700608 that were taken randomly from assembly line.During the testing no issues or discrepancies were found than can lead to the condition reported by the customer.A device history record review shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed.In order to perform a proper investigation and determine the root cause it is necessary to have the device involved in the complaint.If the sample becomes available this investigation will be updated with the evaluation results.
|
|
Event Description
|
Customer complaint alleges "during preparation prior to use, sterilized water could not be sprayed out from the nebulizer adaptor." alleged defect reported as in preparation for patient use.No report of patient injury or consequence.A new unit was obtained for use.
|
|
Manufacturer Narrative
|
Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was contamination on the internal thread of the adaptor.No other issues were found.Functional testing was also performed and the sample passed the tests.No issues were encountered.Based on the investigation performed, the reported complaint could not be confirmed.No issues were found with the returned sample.The device functioned as intended.
|
|
Event Description
|
Customer complaint alleges "during preparation prior to use, sterilized water could not be sprayed out from the nebulizer adaptor." alleged defect reported as in preparation for patient use.No report of patient injury or consequence.A new unit was obtained for use.
|
|
Search Alerts/Recalls
|