TPLC - Total Product Life Cycle

• Device: compressor, air, portable
• Regulation Description: Portable air compressor.
• Product Code: BTI
• Regulation Number: 868.6250
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BEAR MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIRD PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
EMG
	SUBSTANTIALLY EQUIVALENT	1
ERIE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
EVENT MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
HAMILTON
	SUBSTANTIALLY EQUIVALENT	1
IMPACT INSTRUMENTATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL INDUSTRIES AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	4
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
NEWPORT
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PRECISION MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
SIEMENS
	SUBSTANTIALLY EQUIVALENT	2
THE JOHN BUNN CO.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Failure to power-up	22
Malfunction	8
Defective item	6
Device inoperable	5
Overheating of device or device component	5
Failure to run on AC/DC	4
Decrease in pressure	3
Fuse, blown	3
Spark	3
Device operates differently than expected	2
Failure to deliver	2
Smoking	2
Electrical issue	2
Fire	2
Leak	1
Melted	1
Device emits odor	1
Air leak	1
Failure to cycle	1
Loss of power	1
Device stops intermittently	1
Inappropriate shock	1
Out-of-box failure	1
Device displays error message	1
No code available	1
Total Device Problems	80

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	1	0	0	0	0	0	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Draeger Medical, Inc.	II	Apr-05-2007