AIRFLOW RESUSCITATION BAG
Received Sep 30, 2014 · Event occurred Feb 18, 2014
Report 2246980-2014-00032 · MDR key 4147213
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 (B)(4) 2014 BY (B)(6) TO VENTLAB, LLC. THIS EFFORT CONSISTS OF 48 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 PATIENT WAS CODING AND USED RESUSCITATION BAG. VALVE WOULD NOT ALLOW ANY AIR FLOW DURING PATIENT USE. RESOLVED PROBLEM BY OBTAINING ANOTHER RESUSCITATION BAG. CONFIRMED WITH HOSPITAL STAFF THAT THE PATIENT PASSED AWAY DUE TO THEIR MEDICAL CONDITION. DELAY TO OBTAIN SECOND BAG DID NOT CAUSE DEATH.
Remedial action
- Recall