DEVILBISS OXYGEN CONSERVING DEVICE
Received Jan 10, 2013 · Event occurred Dec 6, 2012
Report 2515872-2013-00003 · MDR key 2921920
Device
Product problems
- Device Emits Odor
Patient
UNK
- Burning Sensation
- Loss of consciousness
Narrative
Additional Manufacturer Narrative
"(B)(6) HAS STATED THAT THE PT IS UNWILLING TO ALLOW THEM TO PICK UP THE EQUIPMENT FOR ASSESSMENT. APPARENTLY THE PT HAD BEEN USING THE CYLINDER AND CONSERVING DEVICE WITHOUT ISSUE EARLIER IN THAT SAME DAY. AT THIS POINT WE ARE UNABLE TO PROCEED WITH ANY FURTHER INVESTIGATION UNTIL THE EQUIPMENT IS RETRIEVED BY (B)(6). (B)(6) HAS NOTIFIED THE PT THAT WE WILL BE UNABLE TO FURTHER INVESTIGATE THIS INCIDENT WITHOUT EVALUATING THE EQUIPMENT."
Description of Event or Problem
END USER STATED SHE WAS AT HOME AND PLACED HER OCD (OXYGEN CONSERVING DEVICE) ON A FRESH B-TANK AROUND 3:30 PM ON (B)(6) 2012. END USER APPROXIMATED THE TIME AS SHE WAS NOT EXACTLY SURE WHEN THIS INCIDENT OCCURRED. WHEN SHE TOOK HER FIRST BREATH FROM THE NEW TANK, SHE STATED SHE FELT A SLOW BURN. SHE WENT TO INSTALL ANOTHER TANK AND TOOK A SECOND BREATH FROM THE CURRENT O2 SETUP. THE SECOND BREATH ALSO CAUSED A BURNING, WHICH SHE DESCRIBED AS BREATHING IN ACID AND THAT THE SMELL WAS HARSH. SHE WAS ABLE TO BRING HER DOG BACK INSIDE HER HOME AND CALLED 911 BEFORE PASSING OUT. SHE WAS TAKEN BY AMBULANCE TO THE HOSPITAL WHERE SHE STATED SHE WAS PLACED ON A VENTILATOR AS PART OF HER TREATMENT. THE LOCAL BRANCH MADE SEVERAL ATTEMPTS TO RECOVER AND QUARANTINE THE EQUIPMENT INVOLVED BUT THE END USER IS REFUSING TO RETURN THE EQUIPMENT.