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	2
SUNSET HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K201418 Sunset Heated CPAP Tube

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	288	289
Leak/Splash	287	290
Crack	116	117
Fluid/Blood Leak	54	56
Break	48	49
Material Split, Cut or Torn	39	39
Therapeutic or Diagnostic Output Failure	37	37
Failure of Device to Self-Test	25	25
Connection Problem	21	21
Material Puncture/Hole	15	15
Mechanical Problem	14	14
Disconnection	11	11
Loose or Intermittent Connection	10	10
Degraded	10	10
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Fracture	7	7
Detachment of Device or Device Component	6	6
Material Integrity Problem	5	5
Material Deformation	5	5
Component Missing	5	5
Misconnection	5	6
Insufficient Heating	4	4
Use of Device Problem	4	5
Moisture or Humidity Problem	4	4
Infusion or Flow Problem	4	4
Failure to Disconnect	3	3
Improper or Incorrect Procedure or Method	3	3
Corroded	3	3
Melted	3	3
Misassembly by Users	3	3
Misassembled	3	3
Obstruction of Flow	3	3
Output Problem	3	3
Fire	3	3
Material Perforation	2	2
Material Twisted/Bent	2	2
Misassembled During Installation	2	2
Overfill	2	2
Protective Measures Problem	2	2
Insufficient Information	2	2
Thermal Decomposition of Device	1	1
Decrease in Pressure	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Discolored	1	1
Contamination /Decontamination Problem	1	1
Product Quality Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Component Misassembled	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Increase in Pressure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	777	785
Low Oxygen Saturation	18	19
Insufficient Information	12	12
Hypoxia	4	4
Aspiration/Inhalation	3	3
Burning Sensation	3	3
Pneumothorax	2	2
Dizziness	2	2
Headache	2	2
Respiratory Arrest	1	1
Abnormal Blood Gases	1	1
Discomfort	1	1
Laceration(s)	1	1
Bradycardia	1	1
Increased Respiratory Rate	1	1
Tachycardia	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