Model Number INFANT FLOW LP GENERATOR/NASAL PRONGS |
Device Problems
Disconnection (1171); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/26/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Yaire medical received lp infant flow generators, from the same lot as the suspect device, from the customer for evaluation.Upon completion of the device evaluations, a follow-up report will be submitted.
|
|
Event Description
|
The customer reported that the exhaust tubing disconnected while the device was in use on a patient.The patient required manual positive pressure ventilation.The customer inspected the tubing and noticed it appeared too large and did not have a proper seal.
|
|
Manufacturer Narrative
|
Results of investigation: vyaire medical received twenty (20) unopened suspect devices, infant flow lp generator/nasal prongs, from the same lot reported and evaluated the devices.An evaluation of the devices did not duplicate the reported issue.No issues were found with the devices.A device history record review was performed and no issues were found.
|
|
Search Alerts/Recalls
|