VENTLAB

Additional Manufacturer Narrative

THE PATIENT WAS DESATURATED AND WAS NOT RECEIVING PROPER VENTILATION. SUMMARY: PRODUCT WAS NOT RETURNED AND LEAK LOCATION COULD NOT BE COMMUNICATED FROM THE CUSTOMER. POTENTIAL ROOT CAUSES HAVE BEEN SHARED WITH THE CUSTOMER. FURTHER INVESTIGATION CANNOT BE COMPLETED WITHOUT RETURNED DEVICES. RA: (B)(4) IDENTIFIES RISK ID # (B)(4) WITH SEVERITY OF 6 FOR LEAK TO SQUEEZE BAG CAUSING A DECREASED DELIVERY OF OXYGEN.

Description of Event or Problem

THE VALVE ATTACHED TO THE BVM WAS NOT FUNCTIONING. THE DOCTOR WAS IN THE PROCESS OF INTUBATING THIS PATIENT. THE RESPIRATORY THERAPIST WAS TRYING TO BAG THE PATIENT PRIOR TO THE DOCTOR PLACING THE TUBE. THE DOCTOR WAS HAVING SOME DIFFICULTY WITH THE INITIAL TUBE SIZE. HE OPTED TO SELECT A DIFFERENT SIZE. AT THIS TIME WE NOTICED THE PATIENT'S OXYGEN SATURATION STARTED TO DROP. THE RESPIRATORY THERAPIST SEEMED TO BE HAVING TROUBLE GETTING A GOOD SEAL WITH THE BAG VALVE MASK. AT THIS TIME PATIENT CARE TECH ASSISTED IN BAGGING WHILE THE RESPIRATORY THERAPIST HELD A GOOD CE CLAMP. THE TECH NOTICED THE BAG SEEMED TO BE A LITTLE EASY TO SQUEEZE AND WE DID NOT OBSERVE ANY CHEST RISE WHILE BAGGING. THE PATIENT'S OXYGEN SATURATION CONTINUED TO DROP. THE DOCTOR THEN FINISHED THE INTUBATION. THE TECH GOT ANOTHER BAG-VALVE-MASK (BVM) FROM THE OMNICELL. THE PATIENT'S OXYGEN SATURATION IMMEDIATELY CAME UP INTO THE UPPER 90S. AFTER COMPLETING THE INTUBATION STAFF CHECKED THE PREVIOUS BVM. IT APPEARS THE VALVE ATTACHED TO THE BVM WAS NOT FUNCTIONING. IT APPEARED THE AIR COMING THROUGH THE BAG ENTERED THE VALVE AND CAME OUT BETWEEN THE VALVE AND THE BAG INSTEAD OF THE EXITING THROUGH THE VALVE INTO THE PATIENT. STAFF HAD SAVED THE BAG AND TURNED IT OVER TO ED LEADERSHIP FOR EVALUATION.

Additional Manufacturer Narrative

THE PATIENT WAS DESATURATED AND WAS NOT RECEIVING PROPER VENTILATION. SUMMARY: PRODUCT WAS NOT RETURNED AND LEAK LOCATION COULD NOT BE COMMUNICATED FROM THE CUSTOMER. POTENTIAL ROOT CAUSES HAVE BEEN SHARED WITH THE CUSTOMER. FURTHER INVESTIGATION CANNOT BE COMPLETED WITHOUT RETURNED DEVICES. RA: RMA-20020 IDENTIFIES RISK ID #R23 WITH SEVERITY OF 6 FOR LEAK TO SQUEEZE BAG CAUSING A DECREASED DELIVERY OF OXYGEN.

Description of Event or Problem

THE VALVE ATTACHED TO THE BVM WAS NOT FUNCTIONING. THE DOCTOR WAS IN THE PROCESS OF INTUBATING THIS PATIENT. THE RESPIRATORY THERAPIST WAS TRYING TO BAG THE PATIENT PRIOR TO THE DOCTOR PLACING THE TUBE. THE DOCTOR WAS HAVING SOME DIFFICULTY WITH THE INITIAL TUBE SIZE. HE OPTED TO SELECT A DIFFERENT SIZE. AT THIS TIME WE NOTICED THE PATIENT'S OXYGEN SATURATION STARTED TO DROP. THE RESPIRATORY THERAPIST SEEMED TO BE HAVING TROUBLE GETTING A GOOD SEAL WITH THE BAG VALVE MASK. AT THIS TIME PATIENT CARE TECH ASSISTED IN BAGGING WHILE THE RESPIRATORY THERAPIST HELD A GOOD CE CLAMP. THE TECH NOTICED THE BAG SEEMED TO BE A LITTLE EASY TO SQUEEZE AND WE DID NOT OBSERVE ANY CHEST RISE WHILE BAGGING. THE PATIENT'S OXYGEN SATURATION CONTINUED TO DROP. THE DOCTOR THEN FINISHED THE INTUBATION. THE TECH GOT ANOTHER BAG-VALVE-MASK (BVM) FROM THE OMNICELL. THE PATIENT'S OXYGEN SATURATION IMMEDIATELY CAME UP INTO THE UPPER 90S. AFTER COMPLETING THE INTUBATION STAFF CHECKED THE PREVIOUS BVM. IT APPEARS THE VALVE ATTACHED TO THE BVM WAS NOT FUNCTIONING. IT APPEARED THE AIR COMING THROUGH THE BAG ENTERED THE VALVE AND CAME OUT BETWEEN THE VALVE AND THE BAG INSTEAD OF THE EXITING THROUGH THE VALVE INTO THE PATIENT. STAFF HAD SAVED THE BAG AND TURNED IT OVER TO ED LEADERSHIP FOR EVALUATION.

Additional Manufacturer Narrative

THE PATIENT WAS DESATURATED AND WAS NOT RECEIVING PROPER VENTILATION.

Description of Event or Problem

THE VALVE ATTACHED TO THE BVM WAS NOT FUNCTIONING. THE DOCTOR WAS IN THE PROCESS OF INTUBATING THIS PATIENT. THE RESPIRATORY THERAPIST WAS TRYING TO BAG THE PATIENT PRIOR TO THE DOCTOR PLACING THE TUBE. THE DOCTOR WAS HAVING SOME DIFFICULTY WITH THE INITIAL TUBE SIZE. HE OPTED TO SELECT A DIFFERENT SIZE. AT THIS TIME WE NOTICED THE PATIENT'S OXYGEN SATURATION STARTED TO DROP. THE RESPIRATORY THERAPIST SEEMED TO BE HAVING TROUBLE GETTING A GOOD SEAL WITH THE BAG VALVE MASK. AT THIS TIME PATIENT CARE TECH ASSISTED IN BAGGING WHILE THE RESPIRATORY THERAPIST HELD A GOOD CE CLAMP. THE TECH NOTICED THE BAG SEEMED TO BE A LITTLE EASY TO SQUEEZE AND WE DID NOT OBSERVE ANY CHEST RISE WHILE BAGGING. THE PATIENT'S OXYGEN SATURATION CONTINUED TO DROP. THE DOCTOR THEN FINISHED THE INTUBATION. THE TECH GOT ANOTHER BAG-VALVE-MASK (BVM) FROM THE OMNICELL. THE PATIENT'S OXYGEN SATURATION IMMEDIATELY CAME UP INTO THE UPPER 90S. AFTER COMPLETING THE INTUBATION STAFF CHECKED THE PREVIOUS BVM. IT APPEARS THE VALVE ATTACHED TO THE BVM WAS NOT FUNCTIONING. IT APPEARED THE AIR COMING THROUGH THE BAG ENTERED THE VALVE AND CAME OUT BETWEEN THE VALVE AND THE BAG INSTEAD OF THE EXITING THROUGH THE VALVE INTO THE PATIENT. STAFF HAD SAVED THE BAG AND TURNED IT OVER TO ED LEADERSHIP FOR EVALUATION.