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
1. K241268 Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH ...
GUANGDONG EDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	2
SUNSET HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	322	323
Leak/Splash	319	322
Crack	137	138
Fluid/Blood Leak	65	67
Break	52	53
Material Split, Cut or Torn	41	41
Therapeutic or Diagnostic Output Failure	40	40
Insufficient Heating	30	30
Disconnection	30	30
Failure of Device to Self-Test	28	28
Connection Problem	22	22
Material Puncture/Hole	17	17
Loose or Intermittent Connection	16	16
Mechanical Problem	14	14
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Degraded	11	11
Detachment of Device or Device Component	11	11
Fracture	7	7
Melted	6	6
Use of Device Problem	6	7
Component Missing	6	6
Misconnection	5	6
Moisture or Humidity Problem	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Material Deformation	5	5
Material Integrity Problem	5	5
Infusion or Flow Problem	4	4
Failure to Disconnect	3	3
Output Problem	3	3
Misassembly by Users	3	3
Obstruction of Flow	3	3
Improper or Incorrect Procedure or Method	3	3
Fitting Problem	3	3
Material Perforation	3	3
Misassembled	3	3
Corroded	3	3
Fire	3	3
Overfill	2	2
Insufficient Information	2	2
Appropriate Term/Code Not Available	2	2
Protective Measures Problem	2	2
Misassembled During Installation	2	2
Ambient Temperature Problem	2	2
Material Twisted/Bent	2	2
Mechanics Altered	1	1
Installation-Related Problem	1	1
No Flow	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Deformation Due to Compressive Stress	1	1
Contamination /Decontamination Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	833	841
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
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