InjuryBTM
AIRFLOW RESUSCITATION BAG
Received Oct 2, 2014 · Event occurred Jul 15, 2013
Report 2246980-2014-00045 · MDR key 4151576
Device
Product problems
- Failure to Deliver
- No Flow
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS BELATED MDR IS BEING SUBMITTED AS PART OF OUR REMEDIATION EFFORTS IN RESPONSE TO THE FDA FORM 483 NOTIFICATION ISSUED ON JUNE 4, 2014 BY (B)(4) TO VENTLAB, LLC. THIS EFFORT CONSISTS OF (B)(4) MDR'S. THE AFFECTED DEVICE WAS NOT INVESTIGATED. HOWEVER, VENTLAB PERFORMED QUALITY TRENDING, PRODUCT INVESTIGATION AND CORRECTIVE ACTIONS TO SOLVE THE ROOT CAUSES. THE SOLUTIONS WERE IMPLEMENTED LAST YEAR AND A RECALL WAS INITIATED IN MAY OF THIS YEAR.
Description of Event or Problem
THE DUCKBILL VALVE ON THE RESUSCITATION BAG IS STUCK. DURING PATIENT USE. NO DEATH OR SERIOUS INJURY REPORTED.
Remedial action
- Recall