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
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
TELEFLEX MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	312	312
Gas/Air Leak	184	184
Crack	105	105
Insufficient Heating	72	72
Disconnection	65	65
Break	56	56
Therapeutic or Diagnostic Output Failure	42	42
Material Split, Cut or Torn	41	41
Failure of Device to Self-Test	29	29
Connection Problem	25	25
Fluid/Blood Leak	20	20
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Loose or Intermittent Connection	17	17
Material Puncture/Hole	15	15
Detachment of Device or Device Component	15	15
Temperature Problem	14	14
Degraded	13	13
Melted	11	11
Moisture or Humidity Problem	11	11
Use of Device Problem	10	10
No Apparent Adverse Event	8	8
Material Separation	7	7
Mechanical Problem	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Ambient Temperature Problem	6	6
Device Handling Problem	6	6
Material Perforation	5	5
Component Missing	5	5
Material Deformation	5	5
Misconnection	5	5
Fracture	4	4
Infusion or Flow Problem	4	4
Output Problem	4	4
Device Displays Incorrect Message	4	4
Obstruction of Flow	3	3
Failure to Disconnect	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Corroded	3	3
Fire	3	3
Thermal Decomposition of Device	3	3
Misassembled	3	3
Improper or Incorrect Procedure or Method	3	3
Fitting Problem	3	3
Device Fell	3	3
Insufficient Information	3	3
Appropriate Term/Code Not Available	2	2
Misassembled During Installation	2	2
Overheating of Device	2	2
Air Leak	2	2
Device Alarm System	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	528	528
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	27	27
Insufficient Information	8	8
Bradycardia	4	4
Aspiration/Inhalation	3	3
Burning Sensation	3	3
Hypoxia	3	3
Hypoventilation	2	2
Dizziness	2	2
Burn(s)	2	2
Headache	2	2
Death	1	1
Pneumothorax	1	1
No Code Available	1	1
Respiratory Arrest	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

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