TPLC - Total Product Life Cycle

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Device	cleaner, ultrasonic, medical instrument
Product Code	FLG
Regulation Number	880.6150
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	14	14
Fire	8	8
Patient-Device Incompatibility	7	7
Improper or Incorrect Procedure or Method	6	6
Fluid/Blood Leak	6	6
Leak/Splash	5	5
Device Operates Differently Than Expected	5	5
Use of Device Problem	5	5
Insufficient Information	4	4
Improper Chemical Reaction	4	4
Smoking	4	4
Inappropriate/Inadequate Shock/Stimulation	3	3
Device Emits Odor	3	3
Thermal Decomposition of Device	3	3
Unintended Electrical Shock	3	3
Appropriate Term/Code Not Available	2	2
Device Reprocessing Problem	2	2
Problem with Removal of Enzymatic Cleaner	2	2
Product Quality Problem	2	2
Solder Joint Fracture	2	2
Chemical Spillage	2	2
Contamination /Decontamination Problem	2	2
Facilities Issue	1	1
Failure of Device to Self-Test	1	1
Output below Specifications	1	1
Scratched Material	1	1
Device Difficult to Maintain	1	1
No Apparent Adverse Event	1	1
Obstruction of Flow	1	1
Arcing	1	1
Device Displays Incorrect Message	1	1
False Positive Result	1	1
Misassembled	1	1
Excess Flow or Over-Infusion	1	1
Labelling, Instructions for Use or Training Problem	1	1
Positioning Failure	1	1
Disconnection	1	1
Electrical /Electronic Property Problem	1	1
Circuit Failure	1	1
Loss of or Failure to Bond	1	1
Break	1	1
Noise, Audible	1	1
Patient Device Interaction Problem	1	1
Lack of Effect	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	19	19
No Consequences Or Impact To Patient	9	9
Corneal Edema	7	7
No Clinical Signs, Symptoms or Conditions	6	6
Electric Shock	5	5
No Information	5	5
Irritation	4	4
Rash	4	4
Insufficient Information	4	4
Swelling	3	4
Headache	3	3
Hypersensitivity/Allergic reaction	3	3
Reaction	3	4
Chemical Exposure	3	3
Complaint, Ill-Defined	2	2
Injury	2	2
Not Applicable	2	2
No Code Available	2	2
Shock	2	2
Skin Irritation	1	1
Burning Sensation	1	1
Respiratory Distress	1	1
Pain	1	1
Peeling	1	1
Dyspnea	1	1
Fall	1	1
Stacking Breaths	1	1
Abdominal Pain	1	1
Exposure to Body Fluids	1	1
Burn(s)	1	1
Cough	1	1
Eye Pain	1	1
Skin Inflammation/ Irritation	1	1
Swelling/ Edema	1	1
Needle Stick/Puncture	1	1
Caustic/Chemical Burns	1	1
Ulcer	1	1
Discomfort	1	2
No Patient Involvement	1	1
Alteration In Body Temperature	1	2