TPLC - Total Product Life Cycle

• Device: washer of body waste receptacles
• Product Code: FLH
• Regulation Number: 880.6800
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	8	8
2015	9	9
2016	1	1
2017	6	6
2019	6	6
2020	5	5
2021	5	5
2022	6	6
2023	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fire	10	10
Fluid/Blood Leak	6	6
Use of Device Problem	6	6
Leak/Splash	5	5
Device Emits Odor	4	4
Device Displays Incorrect Message	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Smoking	3	3
Defective Component	2	2
Break	2	2
Device Operates Differently Than Expected	2	2
Electrical Shorting	2	2
Insufficient Information	2	2
Noise, Audible	1	1
Failure to Auto Stop	1	1
Gas/Air Leak	1	1
Installation-Related Problem	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Moisture or Humidity Problem	1	1
Difficult to Open or Close	1	1
Output Problem	1	1
Temperature Problem	1	1
Thermal Decomposition of Device	1	1
Charred	1	1
Electrical /Electronic Property Problem	1	1
Overheating of Device	1	1
Off-Label Use	1	1
Fumes or Vapors	1	1
Sparking	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	12	12
No Known Impact Or Consequence To Patient	12	12
No Clinical Signs, Symptoms or Conditions	12	12
Injury	4	4
Sore Throat	4	4
Electric Shock	3	3
Insufficient Information	2	2
No Consequences Or Impact To Patient	2	2
Fall	2	2
Laceration(s)	1	1
Bruise/Contusion	1	1
Burn(s)	1	1
Physical Entrapment	1	1
Discomfort	1	1
Caustic/Chemical Burns	1	1
Blister	1	1