inforMED
InjuryNFB

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

Model number

EVOLUTION OM-900

Product 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.