TPLC - Total Product Life Cycle

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Device	humidifier, non-direct patient interface (home-use)
Product Code	KFZ
Regulation Number	868.5460
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fire	253	253
Smoking	73	73
Use of Device Problem	51	51
Melted	50	50
Adverse Event Without Identified Device or Use Problem	37	37
Improper or Incorrect Procedure or Method	28	28
Thermal Decomposition of Device	27	27
Patient Device Interaction Problem	26	26
Device Emits Odor	22	22
Break	17	17
Fluid/Blood Leak	17	17
Labelling, Instructions for Use or Training Problem	17	17
Device Handling Problem	17	17
Sparking	14	14
Overheating of Device	14	14
Burst Container or Vessel	13	13
Device Operates Differently Than Expected	12	12
Insufficient Information	11	11
Device Tipped Over	10	10
Human-Device Interface Problem	10	10
Unexpected Therapeutic Results	9	9
Noise, Audible	6	6
Leak/Splash	5	5
Nonstandard Device	5	5
Component Falling	4	4
Device Inoperable	4	4
Structural Problem	3	3
Defective Device	3	3
Hole In Material	3	3
Temperature Problem	3	3
Unintended Ejection	3	3
Malposition of Device	3	3
No Apparent Adverse Event	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Detachment Of Device Component	2	2
Mechanical Problem	2	2
Material Integrity Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Failure to Shut Off	2	2
Device Slipped	2	2
Precipitate in Device or Device Ingredient	1	1
Flare or Flash	1	1
Improper Flow or Infusion	1	1
Misconnection	1	1
Device Unsafe to Use in Environment	1	1
Explosion	1	1
Residue After Decontamination	1	1
Material Discolored	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	174	174
No Consequences Or Impact To Patient	161	161
Partial thickness (Second Degree) Burn	73	73
Burn(s)	44	44
No Clinical Signs, Symptoms or Conditions	32	32
Insufficient Information	23	23
Full thickness (Third Degree) Burn	18	18
Superficial (First Degree) Burn	18	18
Burn, Thermal	16	16
No Information	9	9
Complaint, Ill-Defined	4	4
Injury	4	4
Erythema	3	3
Swelling	3	3
Respiratory Distress	2	2
No Code Available	2	2
Electric Shock	2	2
Blister	2	2
Cough	2	2
Not Applicable	1	1
Aspiration/Inhalation	1	1
Bone Fracture(s)	1	1
Eye Burn	1	1
Chemical Exposure	1	1
Skin Discoloration	1	1
Hypersensitivity/Allergic reaction	1	1
Fever	1	1
Foreign Body In Patient	1	1
Chest Pain	1	1
Vomiting	1	1
Viral Infection	1	1
Death	1	1
Fall	1	1
Laceration(s)	1	1
Pain	1	1
Scar Tissue	1	1
Anxiety	1	1
Syncope	1	1
Loss of Vision	1	1
Patient Problem/Medical Problem	1	1
Sore Throat	1	1
Low Oxygen Saturation	1	1