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	19
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	3
LIFE SUPPORT PRODUCTS
	SUBSTANTIALLY EQUIVALENT	6
MCKESSON
	SUBSTANTIALLY EQUIVALENT	1
MERCURY MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
NELLCOR PURITAN BENNETT
	SUBSTANTIALLY EQUIVALENT - KIT	1
	SUBSTANTIALLY EQUIVALENT	15
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
No flow	72
Failure to deliver	70
Device Issue	27
Failure to separate	20
Defective item	19
Inflation issue	8
Device damaged prior to use	7
Crack	7
Device operates differently than expected	7
Detachment of device component	6
Mechanical issue	6
Misassembled	6
Use of Device Issue	5
Deployment issue	5
Seal, defective	4
Unknown (for use when the device problem is not known)	4
Gas delivery system failure	4
Disconnection	4
Collapse	3
Loose or intermittent connection	3
Component missing	3
Component or accessory incompatibility	3
Maintenance does not comply to manufacturers recommendations	3
Device handling issue	3
No code available	2
Detachment of device or device component	2
No Known Device Problem	2
Torn material	2
Dislodged or dislocated	2
Imprecision	2
Air leak	2
Blockage within device or device component	2
Deflation, cause unknown	2
Deflation issue	1
Difficult to deploy	1
Cross connection	1
Decoupling	1
Dislodged	1
Energy output to patient tissue incorrect	1
Fire	1
Restricted flowrate	1
Break	1
Burn of device or device component	1
Device Cleaning Issue	1
Device clogged	1
Component(s), broken	1
Connection error	1
Defective component	1
Valve(s), defective	1
Magnet mode discrepancy	1
Valve(s), failure of	1
Fitting problem	1
Hole in material	1
Leak	1
Pressure sensor failure	1
Seal, incorrect	1
Stuck in inspiratory or expiratory phase	1
Improper device output	1
Improper flow or infusion	1
Delivery system failure	1
Residue after decontamination	1
Aspiration issue	1
Blocked connection	1
Pressure, insufficient	1
Malfunction	1
Dent in material	1
No Information	1
Total Device Problems	351