TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
CAREFUSION
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION INC
	SUBSTANTIALLY EQUIVALENT	2
DRAEGERWERK AG & CO. KGAA
	SUBSTANTIALLY EQUIVALENT	1
EXCELERON MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
FLEXICARE MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FLEXICARE MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
PLASTIFLEX GROUP NV
	SUBSTANTIALLY EQUIVALENT	1
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUNSET HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	418	418
Crack	358	358
Gas/Air Leak	177	177
Insufficient Heating	159	159
Break	133	133
Disconnection	114	114
Temperature Problem	94	94
Device Operates Differently Than Expected	84	84
Failure of Device to Self-Test	51	51
Hole In Material	49	49
Connection Problem	44	44
Therapeutic or Diagnostic Output Failure	42	42
Moisture or Humidity Problem	41	41
Material Split, Cut or Torn	40	40
Device Issue	34	34
Loose or Intermittent Connection	31	31
Melted	31	31
Device Displays Incorrect Message	28	28
Air Leak	23	23
Fluid/Blood Leak	22	22
Incorrect, Inadequate or Imprecise Result or Readings	21	21
Detachment Of Device Component	17	17
Detachment of Device or Device Component	17	17
Material Puncture/Hole	15	15
Device Damaged Prior to Use	13	13
Degraded	13	13
Power Problem	13	13
Material Separation	12	12
Use of Device Problem	11	11
Failure to Power Up	11	11
Device Slipped	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Device Handling Problem	9	9
Cut In Material	9	9
Overheating of Device	8	8
No Apparent Adverse Event	8	8
Insufficient Information	7	7
Material Deformation	6	6
Mechanical Problem	6	6
Fitting Problem	6	6
Pressure Problem	6	6
Material Integrity Problem	6	6
Ambient Temperature Problem	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Material Perforation	6	6
Decrease in Pressure	5	5
Split	5	5
Component Missing	5	5
Infusion or Flow Problem	4	4
Thermal Decomposition of Device	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	509	509
No Known Impact Or Consequence To Patient	462	462
No Patient Involvement	428	428
No Consequences Or Impact To Patient	291	291
Low Oxygen Saturation	53	53
No Information	30	30
No Code Available	8	8
Bradycardia	7	7
Insufficient Information	7	7
Tachycardia	6	6
Aspiration/Inhalation	4	4
Hypoxia	3	3
Increased Respiratory Rate	3	3
Cardiac Arrest	3	3
Burning Sensation	3	3
Full thickness (Third Degree) Burn	2	2
Headache	2	2
Injury	2	2
Burn(s)	2	2
Dizziness	2	2
Respiratory Distress	2	2
Hypoventilation	2	2
Patient Problem/Medical Problem	2	2
Fever	1	1
Needle Stick/Puncture	1	1
Alteration In Body Temperature	1	1
Exposure to Body Fluids	1	1
Dyspnea	1	1
Laceration(s)	1	1
Scar Tissue	1	1
Respiratory Arrest	1	1
Fluid Discharge	1	1
Pneumothorax	1	1
Pulmonary Edema	1	1
Death	1	1
Therapeutic Response, Decreased	1	1
Partial thickness (Second Degree) Burn	1	1
Unspecified Respiratory Problem	1	1
Unspecified Infection	1	1
Extubate	1	1
Irritability	1	1
Unspecified Vascular Problem	1	1
High Blood Pressure/ Hypertension	1	1
Respiratory Failure	1	1
Increased Peak Expiratory Flow rate	1	1