DeathNFB
DEVILBISS
Received Jul 5, 2017
Report 2438477-2017-00056 · MDR key 6687684
Device
Product problems
- No Flow
- No Flow
Patient
Not reported
- Death
- Death
Narrative
Description of Event or Problem
(B)(4) RECEIVED NOTICE OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR THAT (B)(4) IMPORTS AND DISTRIBUTES. THE PATIENT WAS STAYING IN A HOSPICE AND USING THE OXYGEN CONCENTRATOR WHEN ALLEGEDLY THE UNIT FAILED OVERNIGHT AND THE PATIENT DIED. THE UNIT WAS EVALUATED BY (B)(4) AND IT WAS CONFIRMED THAT A FILTER WAS NOT INSTALLED CORRECTLY LEADING TO A MALFUNCTION AND FAILURE OF THE UNIT. THIS ADVERSE EVENT IS CURRENTLY UNDER LEGAL CONTROL.