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
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
1. K234032 Hudson RCI Dri-Tech Breathing Circuits; HUD99035/D ...
SUNSET HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	335	335
Gas/Air Leak	268	268
Crack	123	123
Insufficient Heating	72	72
Disconnection	66	66
Break	56	56
Material Split, Cut or Torn	42	42
Therapeutic or Diagnostic Output Failure	42	42
Fluid/Blood Leak	30	30
Failure of Device to Self-Test	29	29
Connection Problem	29	29
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Loose or Intermittent Connection	18	18
Material Puncture/Hole	16	16
Detachment of Device or Device Component	15	15
Temperature Problem	14	14
Degraded	13	13
Melted	13	13
Moisture or Humidity Problem	13	13
Mechanical Problem	11	11
Use of Device Problem	10	10
No Apparent Adverse Event	8	8
Fracture	7	7
Material Separation	7	7
Ambient Temperature Problem	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Material Perforation	6	6
Device Handling Problem	6	6
Misconnection	5	5
Component Missing	5	5
Material Deformation	5	5
Misassembly by Users	4	4
Insufficient Information	4	4
Infusion or Flow Problem	4	4
Device Displays Incorrect Message	4	4
Output Problem	4	4
Corroded	3	3
Misassembled	3	3
Fire	3	3
Failure to Disconnect	3	3
Obstruction of Flow	3	3
Fitting Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Thermal Decomposition of Device	3	3
Device Fell	3	3
Misassembled During Installation	2	2
Device Alarm System	2	2
Air Leak	2	2
Detachment Of Device Component	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	652	652
No Patient Involvement	146	146
No Known Impact Or Consequence To Patient	96	96
No Consequences Or Impact To Patient	77	77
Low Oxygen Saturation	30	30
Insufficient Information	10	10
Bradycardia	4	4
Hypoxia	4	4
Aspiration/Inhalation	3	3
Burning Sensation	3	3
Burn(s)	2	2
Headache	2	2
Hypoventilation	2	2
Pneumothorax	2	2
Dizziness	2	2
Abnormal Blood Gases	1	1
Cardiac Arrest	1	1
Death	1	1
Dyspnea	1	1
Laceration(s)	1	1
Tachycardia	1	1
Irritability	1	1
Increased Peak Expiratory Flow rate	1	1
Respiratory Failure	1	1
Increased Respiratory Rate	1	1
Full thickness (Third Degree) Burn	1	1
No Code Available	1	1
Unspecified Vascular Problem	1	1
Respiratory Arrest	1	1
Unspecified Respiratory Problem	1	1