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
DRAEGERWERK AG & CO. KGAA
	SUBSTANTIALLY EQUIVALENT	1
EXCELERON MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
1. K241268 Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH ...
GUANGDONG EDA TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
SUNSET HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	351	351
Gas/Air Leak	304	304
Crack	135	135
Insufficient Heating	72	72
Disconnection	66	66
Break	56	56
Therapeutic or Diagnostic Output Failure	42	42
Material Split, Cut or Torn	42	42
Fluid/Blood Leak	41	41
Connection Problem	33	33
Failure of Device to Self-Test	29	29
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Loose or Intermittent Connection	19	19
Material Puncture/Hole	19	19
Detachment of Device or Device Component	17	17
Temperature Problem	14	14
Melted	13	13
Mechanical Problem	13	13
Degraded	13	13
Moisture or Humidity Problem	13	13
Use of Device Problem	10	10
No Apparent Adverse Event	8	8
Fracture	7	7
Material Separation	7	7
Ambient Temperature Problem	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Device Handling Problem	6	6
Material Deformation	6	6
Material Perforation	6	6
Misconnection	5	5
Component Missing	5	5
Output Problem	4	4
Insufficient Information	4	4
Device Displays Incorrect Message	4	4
Misassembly by Users	4	4
Infusion or Flow Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Failure to Disconnect	3	3
Misassembled	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Thermal Decomposition of Device	3	3
Fitting Problem	3	3
Obstruction of Flow	3	3
Material Integrity Problem	3	3
Device Fell	3	3
Fire	3	3
Material Twisted/Bent	2	2
Material Discolored	2	2
Air Leak	2	2
Misassembled During Installation	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	730	730
No Patient Involvement	146	146
No Known Impact Or Consequence To Patient	96	96
No Consequences Or Impact To Patient	77	77
Low Oxygen Saturation	30	30
Insufficient Information	11	11
Bradycardia	4	4
Hypoxia	4	4
Aspiration/Inhalation	3	3
Burning Sensation	3	3
Hypoventilation	2	2
Pneumothorax	2	2
Dizziness	2	2
Burn(s)	2	2
Headache	2	2
Death	1	1
No Code Available	1	1
Respiratory Arrest	1	1
Abnormal Blood Gases	1	1
Cardiac Arrest	1	1
Dyspnea	1	1
Laceration(s)	1	1
Tachycardia	1	1
Increased Respiratory Rate	1	1
Unspecified Respiratory Problem	1	1
Irritability	1	1
Unspecified Vascular Problem	1	1
Respiratory Failure	1	1
Full thickness (Third Degree) Burn	1	1
Increased Peak Expiratory Flow rate	1	1