SPUR® II ADULT RESUSCITATOR SINGLE PATIENT USE RESUSCITATOR
Received Aug 8, 2023 · Event occurred Jul 13, 2023
Report 17479300 · MDR key 17479300
Device
Patient
27740 DA · Male
- Failure of Implant
- Low Oxygen Saturation
- Diminished Pulse Pressure
- Failure of Implant
- Low Oxygen Saturation
- Diminished Pulse Pressure
Narrative
Description of Event or Problem
PATIENT WAS INTUBATED. END-TIDAL CARBON DIOXIDE (ETCO2) CAP WAS PLACED AND ACTIVATED VIA AN AMBU A/S SPUR II ADULT RESUSCITATOR BAG TO CONFIRM PROPER PLACEMENT OF ENDOTRACHEAL TUBE (EET). ETCO2 DID NOT SHOW COLOR CHANGE. ETT WAS IMMEDIATELY REMOVED AND REPLACED. AFTER THE 3RD ATTEMPT OF FAILED ETCO2 COLOR CHANGE, VIA AMBU BAG, AMBU BAG WAS REPLACED. POSITIVE COLOR CHANGE WAS ACHIEVED AND PATIENTS SATS BEGAN TO RISE. PULSE WAS LOST AND COMPRESSIONS WHERE INITIATED. UPON RETURN OF SPONTANEOUS CIRCULATION (ROSC), PATIENT WAS PLACED ON VENTILATOR. AFTER INSPECTION OF THE AMBU BAG, IT WAS NOTICED THAT THERE WAS A SIZABLE TEAR ON THE INFLATION BAG AT ONE OF THE SEAMS.