TPLC - Total Product Life Cycle

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Device	heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Description	Breathing system heater.
Product Code	BZE
Regulation Number	868.5270
Device Class	2

Premarket Reviews
Manufacturer	Decision
CAREFUSION
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION INC
	SUBSTANTIALLY EQUIVALENT	2
FLEXICARE MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
	SUBSTANTIALLY EQUIVALENT	1
PLASTIFLEX GROUP NV
	SUBSTANTIALLY EQUIVALENT	1
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Crack	178
Insufficient Heating	123
Temperature Problem	92
Leak / Splash	51
Device Issue	34
Disconnection	25
Connection Problem	23
Gas Leak	16
Moisture or Humidity Problem	13
Breathing Circuit	12
Power Problem	12
Air Leak	12
Device Operates Differently Than Expected	10
Break	10
Y-Piece Connector	8
Cut In Material	8
Device Handling Problem	8
Adverse Event Without Identified Device or Use Problem	8
Hole In Material	7
No Apparent Adverse Event	6
Loose or Intermittent Connection	6
Failure to Power Up	6
Melted	6
Material Puncture / Hole	5
Insufficient Information	5
Use of Device Problem	4
Material Integrity Problem	4
Overheating of Device	4
Material Perforation	4
Detachment of Device or device Component	3
Split	3
Physical Property Issue	3
Material Separation	2
Device Operational Issue	2
Increase in Pressure	2
Ambient Temperature Problem	2
Circuit Failure	2
Fracture	2
Changes In Ambient Temperature In Device Environment	1
Charred	1
Ventilation Problem in Device Environment	1
Device Inoperable	1
Degraded	1
Material Discolored	1
Mechanics Altered	1
Sparking	1
Device-Device Incompatibility	1
Human-Device Interface Problem	1
Manufacturing, Packaging or Shipping Problem	1
Device Emits Odor	1
Device Damaged Prior to Use	1
Defective Alarm	1
Latch	1
Thermal Decomposition of Device	1
Fitting Problem	1
Mechanical Jam	1
Connector	1
Detachment Of Device Component	1
Smoking	1
Failure to Deliver	1
Mechanical Problem	1
Torn Material	1
Temperature Probe	1
Intermittent loss of power	1
Patient Device Interaction Problem	1
Material Deformation	1
Total Device Problems	749