inforMED
MalfunctionNFB

CHAD THERAPEUTICS

Received Jul 17, 2015 · Event occurred Jun 19, 2013

Report 2438477-2015-00019 · MDR key 4922505

Device

Generic name

Oxygen Conserver

Manufacturer

Inovo, Inc

Model number

OM-411A

Product problems

  • Gas/Air Leak

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DRIVE MEDICAL RECEIVED NOTICE FROM AN ATTORNEY OF AN INCIDENT INVOLVING AN OXYGEN CONSERVER, A DEVICE DISTRIBUTED BY A DRIVE COMPANY. THE DEVICE ALLEGEDLY CONTAINED A DEFECTIVE SEAL AND/OR CONTAMINATES WITHIN THE PRODUCT THAT CAUSED OXYGEN TO LEAK, RESULTING IN EXTENSIVE DAMAGE TO THE PLAINTIFF'S HOME. THIS REPORT IS BASED ON INFORMATION PROVIDED BY THE ATTORNEY AND HEALTHCARE PROVIDER.