Catalog Number 45372 |
Device Problems
Collapse (1099); Mechanical Problem (1384)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/17/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device involved in this complaint has not been returned to the manufacturer at the time of this report.The investigation into this complaint is still in progress.
|
|
Event Description
|
Customer complaint alleges "when using the insufflator, the valve remained
"collapsed" so another device was used." it was reported there was a delay in ventilation, but the delay caused no clinical consequences for the patient.Another device was available for use.
|
|
Manufacturer Narrative
|
Qn#(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was not returned; however, the customer provided a photo for evaluation.The photo was reviewed and this issue would be detected at the connector assembly and inspection process at the manufacturing facility.
|
|
Event Description
|
Customer complaint alleges "when using the insufflator, the valve remained "collapsed" so another device was used." it was reported there was a delay in ventilation, but the delay caused no clinical consequences for the patient.Another device was available for use.
|
|
Search Alerts/Recalls
|