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
1. K234032 Hudson RCI Dri-Tech Breathing Circuits; HUD99035/D ...
2. K253322 Hudson RCI® Infant Dri-TechTM Breathing Circuits ( ...
SUNSET HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	327	328
Leak/Splash	321	324
Crack	141	142
Fluid/Blood Leak	67	69
Break	52	53
Material Split, Cut or Torn	41	41
Therapeutic or Diagnostic Output Failure	40	40
Disconnection	30	30
Insufficient Heating	30	30
Failure of Device to Self-Test	28	28
Connection Problem	22	22
Material Puncture/Hole	19	19
Loose or Intermittent Connection	18	18
Mechanical Problem	14	14
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Detachment of Device or Device Component	11	11
Degraded	11	11
Fracture	7	7
Melted	6	6
Component Missing	6	6
Use of Device Problem	6	7
Material Deformation	5	5
Misconnection	5	6
Moisture or Humidity Problem	5	5
Material Integrity Problem	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Infusion or Flow Problem	4	4
Overfill	3	3
Improper or Incorrect Procedure or Method	3	3
Obstruction of Flow	3	3
Corroded	3	3
Material Perforation	3	3
Failure to Disconnect	3	3
Output Problem	3	3
Misassembled	3	3
Fire	3	3
Misassembly by Users	3	3
Fitting Problem	3	3
Misassembled During Installation	2	2
Insufficient Information	2	2
Material Twisted/Bent	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	845	853
No Patient Involvement	50	50
No Known Impact Or Consequence To Patient	28	28
Low Oxygen Saturation	23	24
Insufficient Information	12	12
No Consequences Or Impact To Patient	11	11
Hypoxia	4	4
Aspiration/Inhalation	3	3
Burning Sensation	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
Discomfort	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