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

Device Problems
Crack	182
Insufficient Heating	112
Temperature Problem	90
Leak / Splash	58
Disconnection	55
Gas Leak	37
Device Issue	34
Connection Problem	25
Moisture or Humidity Problem	14
Breathing Circuit	13
Air Leak	12
Break	10
Y-Piece Connector	9
Device Handling Problem	9
Cut In Material	8
Loose or Intermittent Connection	8
No Apparent Adverse Event	8
Hole In Material	7
Adverse Event Without Identified Device or Use Problem	7
Device Operates Differently Than Expected	7
Melted	6
Material Puncture / Hole	6
Failure to Power Up	6
Manufacturing, Packaging or Shipping Problem	5
Ambient Temperature Problem	5
Material Perforation	4
Material Integrity Problem	4
Use of Device Problem	4
Power Problem	4
Insufficient Information	4
Physical Property Issue	3
Split	3
Overheating of Device	3
Detachment of Device or device Component	3
Increase in Pressure	2
Degraded	2
Device Operational Issue	2
Circuit Failure	2
Fracture	2
Material Separation	2
Fitting Problem	2
Mechanical Jam	1
Unexpected Shutdown	1
Fluid Leak	1
Connector	1
Detachment Of Device Component	1
Component Misassembled	1
Torn Material	1
Smoking	1
Failure to Deliver	1
Mechanical Problem	1
Tube	1
Temperature Probe	1
Intermittent loss of power	1
Material Deformation	1
Patient Device Interaction Problem	1
Changes In Ambient Temperature In Device Environment	1
Charred	1
Ventilation Problem in Device Environment	1
Device Inoperable	1
Mechanics Altered	1
Material Split, Cut or Torn	1
Material Discolored	1
Device-Device Incompatibility	1
Human-Device Interface Problem	1
Device Damaged Prior to Use	1
Latch	1
Thermal Decomposition of Device	1
Total Device Problems	806

Recalls
Manufacturer		Recall Class	Date Posted
1	Teleflex Medical	I	Jul-15-2019