GECKO NASAL PAD LGE - ROW
Received Aug 13, 2014 · Event occurred Jun 10, 2014
Report 3007573469-2014-00008 · MDR key 4039912
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Obstruction/Occlusion
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A DISORIENTED PT SUFFERING FROM RESPIRATORY FAILURE WAS CONNECTED TO A PHILIPS RESPIRONICS V60 RESPIRATOR. A TRANSPARENT SILICONE NASAL PAD WAS USED WITH THE MASK. THE NASAL PAD HAD SLIPPED AWAY FROM ITS POSITION UNDER THE MASK. IT WAS IN THE PT'S MOUTH, ON TOP OF THE TONGUE. IT COULD BE SEEN BETWEEN THE LIPS AND IT WAS MAKING BREATHING MORE DIFFICULT. THE TIDAL VOLUMES OF THE PT WERE DECREASED BY 50%, BREATHING FREQUENCY INCREASED FURTHER AND SATURATION WENT DOWN. THE TIDAL VOLUMES NORMALIZED AS SOON AS THE NASAL PAD WAS REMOVED FROM THE PT'S MOUTH. BECAUSE OF THE PT'S ILLNESS, INTUBATION WAS NECESSARY SHORTLY AFTER THE INCIDENT.