TPLC - Total Product Life Cycle

• Device: device, transfer, patient, manual
• Product Code: FMR
• Regulation Number: 880.6785
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	8	8
2019	15	15
2020	2	2
2021	8	8
2022	6	6
2023	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Off-Label Use	8	8
Inflation Problem	7	7
Break	5	5
Device Slipped	5	5
Use of Device Problem	5	5
Material Split, Cut or Torn	4	4
Detachment of Device or Device Component	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Structural Problem	2	2
Deflation Problem	2	2
Noise, Audible	2	2
Sparking	2	2
Unintended Deflation	2	2
Patient Device Interaction Problem	1	1
Physical Resistance/Sticking	1	1
Device Fell	1	1
Unintended Electrical Shock	1	1
Disconnection	1	1
Fire	1	1
Mechanical Problem	1	1
Material Rupture	1	1
Arcing	1	1
Improper or Incorrect Procedure or Method	1	1
Protective Measures Problem	1	1
Unintended Movement	1	1
Device Operates Differently Than Expected	1	1
Mechanics Altered	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12	12
Injury	10	10
Rash	8	8
Fall	6	6
No Known Impact Or Consequence To Patient	5	5
Pain	3	3
No Consequences Or Impact To Patient	2	2
Bone Fracture(s)	2	2
Head Injury	2	2
Hematoma	1	1
Joint Dislocation	1	1
Electric Shock	1	1
Patient Problem/Medical Problem	1	1
Pressure Sores	1	1
No Code Available	1	1
Unspecified Musculoskeletal problem	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1