Catalog Number 1882 |
Device Problem
Device Rinsing Issue (2309)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/15/2017 |
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 picture of the alleged defect was not provided.A device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation, and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved in this complaint.If the sample becomes available at a later date, this investigation will be updated with the evaluation results.
|
|
Event Description
|
Customer complaint alleges that "it was found that the mouthpiece and tee were missing from the package." it was reported that the alleged defect was detected during use.It was reported there was a delay in treatment but no harm to the patient.Patient condition reported as "fine.".
|
|
Manufacturer Narrative
|
(b)(4).The sample was returned for evaluation.During the visual inspection, it was revealed that the t-connector and mouthpiece were not returned.The reported complaint of a missing mouthpiece and t-connector was confirmed through visual inspection of the returned sample.The returned components were not received in their original packaging.A review of the device history records (dhr) for the lot number reported did not reveal any manufacturing related issues.Therefore, the root cause of this investigation could not be determined.
|
|
Event Description
|
Customer complaint alleges that " it was found that the mouthpiece and tee were missing from the package".It was reported that the alleged defect was detected during use.It was reported there was a delay in treatment but no harm to the patient.Patient condition reported as "fine".
|
|
Search Alerts/Recalls
|