TPLC - Total Product Life Cycle

• Device: nebulizer (direct patient interface)
• Regulation Description: Nebulizer.
• Product Code: CAF
• Regulation Number: 868.5630
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	3
ACCESS POINT
	SUBSTANTIALLY EQUIVALENT	1
AEROGEN
	SUBSTANTIALLY EQUIVALENT	4
AIRSEP CORP.
	SUBSTANTIALLY EQUIVALENT	2
ALLIED HEALTHCARE PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
AMBU INTERNATIONAL A/S
	SUBSTANTIALLY EQUIVALENT	1
ARMSTRONG
	SUBSTANTIALLY EQUIVALENT	1
BALLARD MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	2
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	4
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	3
CHOICE SMART HEALTH CARE CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
DHD HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	2
EMG
	SUBSTANTIALLY EQUIVALENT	2
GALEMED CORP.
	SUBSTANTIALLY EQUIVALENT	1
GRAHAM-FIELD HEALTH PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
HEALTH & LIFE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOSPIRA INC.
	SUBSTANTIALLY EQUIVALENT	1
HUDSON RESPIRATORY CARE
	SUBSTANTIALLY EQUIVALENT	2
INVACARE CORP.
	SUBSTANTIALLY EQUIVALENT	4
KENDALL
	SUBSTANTIALLY EQUIVALENT	1
K-JUMP HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
MABIS
	SUBSTANTIALLY EQUIVALENT	1
MADA EQUIPMENT CO.
	SUBSTANTIALLY EQUIVALENT	2
MARQUEST MEDICAL PRODUCTS INC
	SUBSTANTIALLY EQUIVALENT	1
MED-EL
	SUBSTANTIALLY EQUIVALENT	3
MEDICAL INDUSTRIES AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	6
MERITS
	SUBSTANTIALLY EQUIVALENT	2
MICROMEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MONAGHAN MEDICAL CORP
	SUBSTANTIALLY EQUIVALENT	3
NELLCOR PURITAN BENNETT
	SUBSTANTIALLY EQUIVALENT	2
NEWPORT
	SUBSTANTIALLY EQUIVALENT	1
OMRON HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	6
PORTEX, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRECISION MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
PROMEDIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
SALTER LABS
	SUBSTANTIALLY EQUIVALENT	9
SENSORMEDICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS
	SUBSTANTIALLY EQUIVALENT	2
SOUTHMEDIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
ST. JUDE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUNRISE MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	7
Ventlab Corporation
	SUBSTANTIALLY EQUIVALENT	2
VITAL SIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Leak	49
Tear, rip or hole in device packaging	45
Other (for use when an appropriate device code cannot be identified)	20
Device Issue	17
Loose or intermittent connection	9
Failure to deliver	8
Improper flow or infusion	8
Product quality issue	7
Break	7
Crack	5
Unstable	5
Component(s), broken	4
Detachment of device component	4
Smoking	3
Sterility	3
Overheating of device or device component	3
Temperature issue	3
Malfunction	3
Output, low	2
Use of Device Issue	2
Noise	2
Air leak	2
Device alarm system issue	1
Failure to Adhere or Bond	1
Blockage within device or device component	1
Component(s), overheating of	1
Connection error	1
Couple, failure to	1
Hole in material	1
Difficult to insert	1
Burn of device or device component	1
Circuit Failure	1
Occlusion within device	1
Device emits odor	1
Fitting problem	1
Valve(s), sticking	1
Inaccurate delivery	1
Seal, defective	1
Incomplete or missing packaging	1
Adaptor, failure of	1
Performance	1
Threader failure	1
Disinfection or Sterilization Issue at User Location	1
Device Contamination with biological material	1
Device operates differently than expected	1
No Information	1
Device handling issue	1
Total Device Problems	236

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Carefusion 211 Inc	II	Aug-12-2011
2	Teleflex Creek Dr	II	Dec-28-2007
3	Thayer Medical Corporation	II	Jul-02-2012