AIRFLOW, VENTLAB
Received Oct 17, 2022 · Event occurred Sep 11, 2022
Report 15619253 · MDR key 15619253
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Sunmed Holdings, LlcCatalog number
AF5140MB
Product problems
- Defective Device
Patient
9125 DA · Male
- Low Oxygen Saturation
- Low Oxygen Saturation
Narrative
Description of Event or Problem
RESPIRATORY THERAPIST (RRT) WAS CALLED TO BEDSIDE (NORTH 8) FOR PATIENT INTUBATION. RRT ARRIVED AT ROOM WITH VENTILATOR AND BEGAN PREPPING EQUIPMENT FOR INTUBATION. RRT CHECK FUNCTIONALITY OF BAG VALVE MASK (BVM) AND SET UP VENTILATOR PRIOR TO INTUBATION. AFTER SUCCESSFUL INTUBATION, BVM WAS PLACED ON ETT WITH CAPNOGRAPHY ADAPTER IN LINE AT THE REQUEST OF MD. BVM MALFUNCTIONED AND PATIENT WAS NOT ABLE TO BE VENTILATED FOR AN UNKNOWN REASON. RRT CALLED FOR ANOTHER BVM WHICH WAS AT THE BEDSIDE. BVM WAS SET UP AND FUNCTIONALITY CHECKED AND PLACED ONTO THE ETT TO VENTILATE PATIENT WITHIN 30-40 SECONDS. DURING THAT TIME, PATIENTS' SPO2 DROPPED TO 45-50% AS WITNESSED BY RRT. PATIENT WAS VENTILATED WITH BVM AND INCREASED TO SPO2 OF 95-100% WITHIN 45-60 SECONDS. PATIENT REMAINS ON MECHANICAL VENTILATOR AND TOLERATING WELL.