TPLC - Total Product Life Cycle

• Device: set, tubing and support, ventilator (w harness)
• Regulation Description: Ventilator tubing.
• Product Code: BZO
• Regulation Number: 868.5975
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOVNA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
HAMILTON
	SUBSTANTIALLY EQUIVALENT	1
HUDSON RESPIRATORY CARE
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SUBSTANTIALLY EQUIVALENT	1
NELLCOR PURITAN BENNETT
	SUBSTANTIALLY EQUIVALENT	1
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
	SUBSTANTIALLY EQUIVALENT	2
SECHRIST INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS
	SUBSTANTIALLY EQUIVALENT	1
THORATEC CORP.
	SUBSTANTIALLY EQUIVALENT	1
Ventlab Corporation
	SUBSTANTIALLY EQUIVALENT	2
VITAL SIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Leak	100
Crack	36
Melted	14
Other (for use when an appropriate device code cannot be identified)	11
Device Issue	7
Hole in material	7
Cut in material	7
Tears, rips, holes in device, device material	6
Loose or intermittent connection	4
Overheating of device or device component	3
Tube(s), splitting of	2
Electrical wires, defective	2
Burn of device or device component	2
Circuit Failure	2
Component(s), broken	1
Detachment of device component	1
Disconnection	1
Heat	1
Malfunction	1
Use of Device Issue	1
Total Device Problems	209

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Fisher & Paykel Healthcare, Ltd.	I	Jan-03-2013