VENTLAB
Received May 25, 2023 · Event occurred Apr 2, 2023
Report 17001489 · MDR key 17001489
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Sunmed Holdings, LlcModel number
AF5140MBPLot number
397480
Product problems
- Inadequacy of Device Shape and/or Size
- Fitting Problem
- Gas/Air Leak
- Incomplete or Inadequate Connection
Patient
18615 DA · Male
- Hypoxia
- Hypoxia
Narrative
Description of Event or Problem
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.