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
GUANGDONG EDA TECHNOLOGY CO., LTD
	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	310	310
Gas/Air Leak	278	278
Crack	104	104
Break	52	52
Material Split, Cut or Torn	41	41
Fluid/Blood Leak	40	40
Therapeutic or Diagnostic Output Failure	40	40
Insufficient Heating	30	30
Disconnection	28	28
Failure of Device to Self-Test	28	28
Connection Problem	22	22
Loose or Intermittent Connection	14	14
Material Puncture/Hole	13	13
Mechanical Problem	12	12
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Detachment of Device or Device Component	11	11
Degraded	11	11
Melted	6	6
Use of Device Problem	6	6
Fracture	5	5
Material Deformation	5	5
Misconnection	5	5
Moisture or Humidity Problem	5	5
Component Missing	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Infusion or Flow Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Material Perforation	3	3
Failure to Disconnect	3	3
Output Problem	3	3
Misassembled	3	3
Misassembly by Users	3	3
Fitting Problem	3	3
Overfill	2	2
Misassembled During Installation	2	2
Material Integrity Problem	2	2
Obstruction of Flow	2	2
Insufficient Information	2	2
Corroded	2	2
Material Twisted/Bent	2	2
Fire	2	2
Appropriate Term/Code Not Available	2	2
Ambient Temperature Problem	2	2
Protective Measures Problem	2	2
Overheating of Device	1	1
Device Displays Incorrect Message	1	1
Deformation Due to Compressive Stress	1	1
No Flow	1	1
Loss of or Failure to Bond	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	729	729
No Patient Involvement	50	50
No Known Impact Or Consequence To Patient	28	28
Low Oxygen Saturation	22	22
Insufficient Information	11	11
No Consequences Or Impact To Patient	11	11
Aspiration/Inhalation	3	3
Burning Sensation	3	3
Hypoxia	3	3
Pneumothorax	2	2
Dizziness	2	2
Bradycardia	2	2
Headache	2	2
Death	1	1
Hypoventilation	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
Increased Peak Expiratory Flow rate	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Vyaire Medical	I	May-09-2025