TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2020	2	2
2021	8	8
2022	6	6
2023	10	10
2024	10	10
2025	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	6	6
Device Slipped	5	5
Break	5	5
Unintended Electrical Shock	5	5
Electro-Static Discharge	5	5
Material Split, Cut or Torn	3	3
Inflation Problem	3	3
Unintended Deflation	2	2
Noise, Audible	2	2
Fire	1	1
Device Fell	1	1
Patient Device Interaction Problem	1	1
Structural Problem	1	1
Mechanics Altered	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Rupture	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment of Device or Device Component	1	1
Protective Measures Problem	1	1
Appropriate Term/Code Not Available	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14	14
Fall	8	8
Electric Shock	5	5
Bone Fracture(s)	3	3
Pain	3	3
Pressure Sores	3	3
Numbness	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Joint Dislocation	1	1
Necrosis	1	1
Unspecified Musculoskeletal problem	1	1
Head Injury	1	1
Loss of Range of Motion	1	1
Insufficient Information	1	1
Laceration(s)	1	1
Swelling/ Edema	1	1
Skin Tears	1	1
Hemorrhage/Bleeding	1	1
Tissue Breakdown	1	1