TPLC - Total Product Life Cycle

• Device: ventilator, emergency, powered (resuscitator)
• Regulation Description: Powered emergency ventilator.
• Product Code: BTL
• Regulation Number: 868.5925
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AIRON CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ALLIED HEALTHCARE PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	7
AMBU INTERNATIONAL A/S
	SUBSTANTIALLY EQUIVALENT	1
ATOM MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
BIOVNA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
IMPACT INSTRUMENTATION, INC.
	SUBSTANTIALLY EQUIVALENT	5
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
LIFE SUPPORT PRODUCTS
	SUBSTANTIALLY EQUIVALENT	8
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
O-TWO SYSTEMS INTL., INC.
	SUBSTANTIALLY EQUIVALENT	7
PNEUPAC LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Failure to cycle	18
Device alarm system issue	10
Malfunction	7
Device Issue	6
Unknown (for use when the device problem is not known)	5
Tidal volume fluctuations	3
Other (for use when an appropriate device code cannot be identified)	3
Failure to deliver	2
Measurements, inaccurate	2
Inadequate service	2
Slippage of device or device component	1
Sticking	1
Air leak	1
Alarm, audible	1
Use of Device Issue	1
Respirator, detachment from	1
False alarm	1
Alarm, failure of low flow	1
Break	1
Collapse	1
Crack	1
Deflation issue	1
Restricted flowrate	1
Intraprocedure, fire or flash during	1
Leak	1
Incorrect measurement	1
Meter	1
Split	1
No Pressure	1
Pressure issue	1
Programming issue	1
Total Device Problems	79

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

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Healthcare, LLC	I	Feb-08-2013
2	GE Healthcare, LLC	I	Dec-26-2012
3	Instrumentation Industries Inc	II	Apr-16-2013
4	Smiths Medical PM, Inc.	II	Jul-04-2007