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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stretcher, wheeled, powered
Product CodeINK
Regulation Number 890.3690
Device Class 2

MDR Year MDR Reports MDR Events
2019 79 328
2020 89 295
2021 114 308
2022 93 393
2023 147 528
2024 24 131

Device Problems MDRs with this Device Problem Events in those MDRs
Intermittent Loss of Power 113 488
Unintended System Motion 85 475
Electrical /Electronic Property Problem 80 244
Mechanical Jam 79 246
Grounding Malfunction 56 148
Mechanical Problem 44 105
Fluid/Blood Leak 26 151
Sharp Edges 25 37
Unintended Movement 15 61
Positioning Failure 14 16
Device Slipped 9 12
Device Fell 9 9
Insufficient Information 7 7
Break 6 6
Patient Device Interaction Problem 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Defective Component 3 3
Fire 2 2
Unintended Electrical Shock 2 2
Output Problem 1 1
Positioning Problem 1 3
No Apparent Adverse Event 1 1
Leak/Splash 1 1
Incorrect Measurement 1 1
No Audible Alarm 1 1
Loss of or Failure to Bond 1 1
Component Missing 1 1
Arcing 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 355 1405
No Patient Involvement 135 535
Insufficient Information 37 54
Pain 16 23
Muscle/Tendon Damage 9 25
Fall 6 10
Laceration(s) 5 5
Electric Shock 5 11
No Consequences Or Impact To Patient 4 14
Bruise/Contusion 3 18
Injury 3 3
Bone Fracture(s) 2 2
Shock 2 4
Concussion 1 1
Discomfort 1 5
Fatigue 1 1
Neck Pain 1 1
Unspecified Musculoskeletal problem 1 4

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Division of Stryker Corporation II Jun-01-2020
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