TPLC - Total Product Life Cycle

Device	ventilator, emergency, manual (resuscitator)
Regulation Description	Manual emergency ventilator.
Product Code	BTM
Regulation Number	868.5915
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALLIED HEALTHCARE PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	4
AMBU INTERNATIONAL A/S
	SUBSTANTIALLY EQUIVALENT	18
ENGINEERED MEDICAL
	SUBSTANTIALLY EQUIVALENT	6
GALEMED CORP.
	SUBSTANTIALLY EQUIVALENT	1
HUDSON RESPIRATORY CARE
	SUBSTANTIALLY EQUIVALENT	2
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
KIRK SPECIALTY
	SUBSTANTIALLY EQUIVALENT	2
LAERDAL MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	2
LIFE SUPPORT PRODUCTS
	SUBSTANTIALLY EQUIVALENT	6
MCKESSON
	SUBSTANTIALLY EQUIVALENT	1
MERCURY MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
NELLCOR PURITAN BENNETT
	SUBSTANTIALLY EQUIVALENT	15
	SUBSTANTIALLY EQUIVALENT - KIT	1
NEOMED
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
O-TWO SYSTEMS INTL., INC.
	SUBSTANTIALLY EQUIVALENT	3
PORTEX, INC.
	SUBSTANTIALLY EQUIVALENT	2
PRECISION MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROMEDIC, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	5
RESUSCITATION ACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
RUSCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS
	SUBSTANTIALLY EQUIVALENT	1
SIMS
	SUBSTANTIALLY EQUIVALENT	3
Ventlab Corporation
	SUBSTANTIALLY EQUIVALENT	2
VITAL SIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	6

Device Problems
Defective item	19
Crack	6
Misassembled	5
Disconnection	4
Gas delivery system failure	4
Detachment of device component	4
Seal, defective	4
Unknown (for use when the device problem is not known)	4
Device damaged prior to use	4
Device Issue	4
Inflation issue	3
Component missing	3
Component or accessory incompatibility	3
Maintenance does not comply to manufacturers recommendations	3
Mechanical issue	3
No flow	2
Failure to deliver	2
Air leak	2
Deflation, cause unknown	2
Deflation issue	1
Difficult to deploy	1
Cross connection	1
Blockage within device or device component	1
Component(s), broken	1
Connection error	1
Hole in material	1
Dislodged	1
Pressure sensor failure	1
Seal, incorrect	1
Stuck in inspiratory or expiratory phase	1
Use of Device Issue	1
Valve(s), failure of	1
Fitting problem	1
Aspiration issue	1
No Known Device Problem	1
Detachment of device or device component	1
Magnet mode discrepancy	1
Valve(s), defective	1
Pressure, insufficient	1
Malfunction	1
Dent in material	1
Total Device Problems	103