TPLC - Total Product Life Cycle

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Device	heater, breathing system w/wo controller (not humidifier or nebulizer
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
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	295	295
Gas/Air Leak	173	173
Crack	84	84
Disconnection	58	58
Break	55	55
Insufficient Heating	53	53
Therapeutic or Diagnostic Output Failure	42	42
Material Split, Cut or Torn	39	39
Failure of Device to Self-Test	29	29
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Loose or Intermittent Connection	17	17
Connection Problem	17	17
Fluid/Blood Leak	15	15
Detachment of Device or Device Component	14	14
Material Puncture/Hole	13	13
Degraded	12	12
Melted	9	9
No Apparent Adverse Event	7	7
Material Separation	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Material Deformation	6	6
Use of Device Problem	6	6
Ambient Temperature Problem	5	5
Device Handling Problem	5	5
Component Missing	5	5
Mechanical Problem	4	4
Output Problem	4	4
Misconnection	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
Fire	3	3
Device Fell	3	3
Moisture or Humidity Problem	3	3
Appropriate Term/Code Not Available	2	2
Protective Measures Problem	2	2
Misassembled	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Perforation	2	2
Thermal Decomposition of Device	2	2
Material Twisted/Bent	2	2
Obstruction of Flow	2	2
Material Discolored	2	2
Misassembled During Installation	2	2
Overfill	2	2
Insufficient Information	2	2
Device Alarm System	2	2
Pressure Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	508	508
No Patient Involvement	113	113
No Known Impact Or Consequence To Patient	67	67
No Consequences Or Impact To Patient	36	36
Low Oxygen Saturation	27	27
Insufficient Information	7	7
Bradycardia	4	4
Aspiration/Inhalation	3	3
Burning Sensation	3	3
Hypoventilation	2	2
Dizziness	2	2
Burn(s)	2	2
Hypoxia	2	2
Headache	2	2
Death	1	1
Pneumothorax	1	1
Respiratory Arrest	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
Full thickness (Third Degree) Burn	1	1
Increased Peak Expiratory Flow rate	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Teleflex Medical	I	Jul-15-2019