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
1. K222822 VentStar Helix dual heated (N) Plus (MP02650), Ven ...
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	318	321
Gas/Air Leak	296	297
Crack	119	120
Break	52	53
Fluid/Blood Leak	46	48
Material Split, Cut or Torn	41	41
Therapeutic or Diagnostic Output Failure	40	40
Insufficient Heating	30	30
Disconnection	29	29
Failure of Device to Self-Test	28	28
Connection Problem	23	23
Material Puncture/Hole	15	15
Loose or Intermittent Connection	14	14
Mechanical Problem	13	13
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Detachment of Device or Device Component	11	11
Degraded	11	11
Fracture	7	7
Use of Device Problem	6	7
Material Deformation	5	5
Misconnection	5	6
Moisture or Humidity Problem	5	5
Melted	5	5
Component Missing	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Material Integrity Problem	4	4
Infusion or Flow Problem	4	4
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
Overfill	2	2
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	778	786
No Patient Involvement	50	50
No Known Impact Or Consequence To Patient	28	28
Low Oxygen Saturation	22	23
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
Hypoventilation	1	1
Death	1	1
Respiratory Arrest	1	1
Abnormal Blood Gases	1	1
Discomfort	1	1
Dyspnea	1	1
Laceration(s)	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