TPLC - Total Product Life Cycle

• Device: stretcher, wheeled, powered
• Regulation Description: Powered wheeled stretcher.
• Product Code: INK
• Regulation Number: 890.3690
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2021	114	310
2022	93	393
2023	147	527
2024	179	572
2025	104	487
2026	20	108

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	112	784
Intermittent Loss of Power	96	417
Electrical /Electronic Property Problem	92	340
Mechanical Jam	73	192
Grounding Malfunction	60	197
Fluid/Blood Leak	43	255
Mechanical Problem	33	51
Sharp Edges	24	37
Positioning Failure	19	21
Device Slipped	14	19
Device Fell	12	12
Insufficient Device Problem Information	7	7
Break	6	6
Patient Device Interaction Problem	5	5
Unintended Electrical Shock	2	2
No Audible Alarm	2	2
Fire	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Defective Component	2	2
Incorrect Measurement	1	2
Unintended Movement	1	1
Component Missing	1	1
Loss of or Failure to Bond	1	1
Battery Problem	1	1
Smoking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	555	2295
Insufficient Information	80	105
Pain	16	49
Muscle/Tendon Damage	10	34
Fall	8	13
Laceration(s)	7	7
Electric Shock	5	14
Exposure to Body Fluids	2	2
Bruise/Contusion	2	14
Bone Fracture(s)	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Altered State of Consciousness	1	1
Convulsion/Seizure	1	1
Unspecified Musculoskeletal problem	1	4
Shock	1	1
Fatigue	1	1
Back pain	1	1
Concussion	1	1
Joint Dislocation	1	1