VYAIRE MEDICAL INC. AIRLIFE¿ VERSO¿ AIRWAY ACCESS ADAPTER; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
|
Back to Search Results |
|
Model Number ADAPTER VERSO ADULT/PED 45 DBL SWVL ELBO |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/19/2023 |
Event Type
malfunction
|
Event Description
|
It was reported to vyaire medical that at the start of endotracheal suctioning, in the process of inserting the suction catheter, the peep valve fell apart.The patient was sedated with a volatile anesthetic (isoflurane).The airlife¿ verso¿ airway access adapter was not broken or chipped.The end users secured two parts and replaced the valve.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
|
|
Manufacturer Narrative
|
H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.H3 other text : device not returned yet.
|
|
Manufacturer Narrative
|
Results of investigation: vyaire medical was able to verify the reported issue.Based on the device history record (dhr), a nonconformance was identified during incoming quality control (iqc) for component 11761.The root cause was identified as the insufficient application of adhesive, where the amount of glue used was below the required rate upon reviewing the drawing for component 11761, it appears that there is no specified pulling test standard mentioned.
|
|
Search Alerts/Recalls
|
|
|