TPLC - Total Product Life Cycle

• 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
SUNSET HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	103	103
2019	134	134
2020	123	123
2021	124	124
2022	152	152
2023	89	89

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	235	235
Gas/Air Leak	145	145
Crack	87	87
Insufficient Heating	72	72
Disconnection	63	63
Break	52	52
Therapeutic or Diagnostic Output Failure	42	42
Material Split, Cut or Torn	34	34
Failure of Device to Self-Test	29	29
Connection Problem	24	24
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Material Puncture/Hole	15	15
Detachment of Device or Device Component	15	15
Temperature Problem	14	14
Loose or Intermittent Connection	14	14
Moisture or Humidity Problem	11	11
Use of Device Problem	10	10
Melted	9	9
Degraded	8	8
No Apparent Adverse Event	8	8
Material Separation	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Ambient Temperature Problem	6	6
Device Handling Problem	6	6
Material Perforation	5	5
Misconnection	4	4
Fluid/Blood Leak	4	4
Device Displays Incorrect Message	4	4
Infusion or Flow Problem	4	4
Material Deformation	4	4
Output Problem	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Obstruction of Flow	3	3
Fitting Problem	3	3
Failure to Disconnect	3	3
Fire	3	3
Thermal Decomposition of Device	3	3
Component Missing	3	3
Improper or Incorrect Procedure or Method	3	3
Device Fell	3	3
Misassembled During Installation	2	2
Device Issue	2	2
Overheating of Device	2	2
Misassembled	2	2
Air Leak	2	2
Device Alarm System	2	2
Material Discolored	2	2
Detachment Of Device Component	2	2
Fracture	2	2
Material Twisted/Bent	2	2
Insufficient Information	2	2
Appropriate Term/Code Not Available	2	2
Pressure Problem	2	2
Protective Measures Problem	2	2
Unintended Movement	1	1
Misassembly by Users	1	1
Mechanical Jam	1	1
Mechanics Altered	1	1
Material Integrity Problem	1	1
Power Problem	1	1
Dent in Material	1	1
Sparking	1	1
Deformation Due to Compressive Stress	1	1
Contamination /Decontamination Problem	1	1
Installation-Related Problem	1	1
Human-Device Interface Problem	1	1
Improper Flow or Infusion	1	1
Device Operates Differently Than Expected	1	1
Device-Device Incompatibility	1	1
Material Disintegration	1	1
Mechanical Problem	1	1
Component Falling	1	1
Complete Blockage	1	1
Decrease in Pressure	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Slipped	1	1
Device Inoperable	1	1
Overfill	1	1
Defective Component	1	1
Insufficient Flow or Under Infusion	1	1
Product Quality Problem	1	1
Intermittent Loss of Power	1	1
Unexpected Shutdown	1	1
Separation Problem	1	1
Noise, Audible	1	1
Patient Device Interaction Problem	1	1
Component Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	375	375
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	28	28
Insufficient Information	6	6
Bradycardia	4	4
Hypoxia	3	3
Hypoventilation	2	2
Burn(s)	2	2
Burning Sensation	2	2
Cardiac Arrest	1	1
Death	1	1
Dyspnea	1	1
Aspiration/Inhalation	1	1
Laceration(s)	1	1
Pneumothorax	1	1
Respiratory Failure	1	1
Increased Respiratory Rate	1	1
Irritability	1	1
Increased Peak Expiratory Flow rate	1	1
Full thickness (Third Degree) Burn	1	1
No Code Available	1	1
Unspecified Respiratory Problem	1	1

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