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
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
SUNSET HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K201418 Sunset Heated CPAP Tube

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	314	314
Gas/Air Leak	237	237
Crack	95	95
Disconnection	60	60
Break	55	55
Insufficient Heating	53	53
Therapeutic or Diagnostic Output Failure	42	42
Material Split, Cut or Torn	41	41
Failure of Device to Self-Test	29	29
Fluid/Blood Leak	28	28
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Loose or Intermittent Connection	17	17
Connection Problem	17	17
Material Puncture/Hole	14	14
Detachment of Device or Device Component	14	14
Degraded	12	12
Mechanical Problem	10	10
Melted	10	10
Material Separation	7	7
No Apparent Adverse Event	7	7
Use of Device Problem	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Fracture	6	6
Moisture or Humidity Problem	5	5
Misconnection	5	5
Material Deformation	5	5
Device Handling Problem	5	5
Component Missing	5	5
Ambient Temperature Problem	5	5
Output Problem	4	4
Infusion or Flow Problem	4	4
Device Fell	3	3
Insufficient Information	3	3
Fire	3	3
Corroded	3	3
Misassembly by Users	3	3
Improper or Incorrect Procedure or Method	3	3
Failure to Disconnect	3	3
Misassembled	3	3
Fitting Problem	3	3
Component Misassembled	2	2
Protective Measures Problem	2	2
Appropriate Term/Code Not Available	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Perforation	2	2
Thermal Decomposition of Device	2	2
Material Twisted/Bent	2	2
Obstruction of Flow	2	2
Material Discolored	2	2
Misassembled During Installation	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	606	606
No Patient Involvement	113	113
No Known Impact Or Consequence To Patient	67	67
No Consequences Or Impact To Patient	36	36
Low Oxygen Saturation	29	29
Insufficient Information	9	9
Bradycardia	4	4
Aspiration/Inhalation	3	3
Burning Sensation	3	3
Hypoxia	3	3
Hypoventilation	2	2
Pneumothorax	2	2
Dizziness	2	2
Burn(s)	2	2
Headache	2	2
Death	1	1
Respiratory Arrest	1	1
Abnormal Blood Gases	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

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