TPLC - Total Product Life Cycle

• Device: mixer, breathing gases, anesthesia inhalation
• Regulation Description: Breathing gas mixer.
• Product Code: BZR
• Regulation Number: 868.5330
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ATOM MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
BIRD PRODUCTS
	SUBSTANTIALLY EQUIVALENT	5
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	1
DRAEGER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
HAMILTON
	SUBSTANTIALLY EQUIVALENT	2
MAXTEC
	SUBSTANTIALLY EQUIVALENT	1
MCKESSON
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEWPORT
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PRAXAIR
	SUBSTANTIALLY EQUIVALENT	1
PRECISION MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
SECHRIST INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHILEY, INC
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS
	SUBSTANTIALLY EQUIVALENT	2
VITAL SIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Not audible alarm	37
Inaccurate delivery	34
Out-of-box failure	23
Device alarm system issue	13
Device operates differently than expected	5
Failure to calibrate	3
False alarm	3
Detachment of device component	2
Inaccurate flowrate	2
Improper gas output	2
Leak	2
Alarm system, failure of gas-leak/loss	1
Other (for use when an appropriate device code cannot be identified)	1
Excess flow or overinfusion	1
Connection error	1
Defective Alarm	1
Delayed alarm	1
Device sensing issue	1
Total Device Problems	133

Recalls
	2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017
Class I	0	0	0	0	0	0	0	0	0	0	0
Class II	0	0	0	0	0	0	0	0	0	0	0
Class III	0	0	0	0	0	0	0	0	0	0	0