EVOLUTION OXYGEN CONSIVERATOR REGULATOR
Received Dec 31, 2013 · Event occurred Dec 28, 2013
Report MW5033691 · MDR key 3554149
Device
Generic name
Evolution Oxygen Consiverator Regulator
Manufacturer
Chad/drive Inovo, IncModel number
EVOLUTION OM-900Product problems
- Device Stops Intermittently
- Failure to Deliver
Patient
63 YR
- Dyspnea
- Low Oxygen Saturation
Narrative
Description of Event or Problem
I REQUIRE OXYGEN 24/7 AND UTILIZE PORTABLE TANKS AND A CHAD/DRIVE EVOLUTION MODEL OM-900 PULSE OXYGEN CONSERVATOR DEVICE WHEN I AM AWAY FROM MY HOUSE. THIS DEVICE (SN (B)(4)) BECAME INTERMITTENT AND FAILED TO PROVIDE OXYGEN IN THE PULSE MODE. I DID NOT REALIZE THAT THE DEVICE WAS MALFUNCTIONING WHILE I WAS WALKING UNTIL I WAS SEVERELY DE-SATURATED AND ABOUT TO PASS OUT. RAPPING THE REGULATOR WITH MY KNUCKLES WOULD TEMPORARILY RESTORE THE FUNCTIONALITY OF THE REGULATOR BUT A FEW MINUTES LATER, THE REGULATOR WOULD AGAIN CEASE TO FUNCTION. THIS IS NOW THE THIRD (3RD) CHAD OM-900 REGULATOR THAT HAS FAILED FOR ME WITH AN IDENTICAL INTERMITTENT CONDITION IN THE PAST YEAR AND NEEDED TO BE REPLACED BY MY OXYGEN PROVIDER. I HAVE CONTACTED MY OXYGEN PROVIDER ((B)(4)) FOR A REPLACEMENT REGULATOR BUT I BELIEVE THE REPETITIVE FAILURE OF THIS MODEL REGULATOR IS DANGEROUS AND A SIGNIFICANT QUALITY ISSUE THAT NEEDS TO BE ADDRESSED. I WANT TO BRING THIS MATTER TO YOUR ATTENTION.