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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	284	284
Gas/Air Leak	214	214
Crack	85	85
Break	52	52
Material Split, Cut or Torn	41	41
Therapeutic or Diagnostic Output Failure	40	40
Insufficient Heating	30	30
Disconnection	28	28
Failure of Device to Self-Test	28	28
Fluid/Blood Leak	27	27
Connection Problem	14	14
Loose or Intermittent Connection	12	12
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Degraded	11	11
Mechanical Problem	10	10
Material Puncture/Hole	10	10
Detachment of Device or Device Component	9	9
Use of Device Problem	6	6
Melted	5	5
Fracture	5	5
Misconnection	5	5
Moisture or Humidity Problem	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Component Missing	5	5
Material Deformation	4	4
Infusion or Flow Problem	4	4
Fitting Problem	3	3
Failure to Disconnect	3	3
Improper or Incorrect Procedure or Method	3	3
Corroded	3	3
Misassembled	3	3
Output Problem	3	3
Misassembled During Installation	2	2
Obstruction of Flow	2	2
Overfill	2	2
Material Twisted/Bent	2	2
Material Perforation	2	2
Insufficient Information	2	2
Misassembly by Users	2	2
Fire	2	2
Ambient Temperature Problem	2	2
Appropriate Term/Code Not Available	2	2
Protective Measures Problem	2	2
Noise, Audible	1	1
Deformation Due to Compressive Stress	1	1
Device Displays Incorrect Message	1	1
Device Slipped	1	1
Overheating of Device	1	1
Pressure Problem	1	1
Device Alarm System	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	606	606
No Patient Involvement	50	50
No Known Impact Or Consequence To Patient	28	28
Low Oxygen Saturation	22	22
No Consequences Or Impact To Patient	11	11
Insufficient Information	9	9
Aspiration/Inhalation	3	3
Burning Sensation	3	3
Hypoxia	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
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