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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 147 527
2024 26 132

Device Problems MDRs with this Device Problem Events in those MDRs
Intermittent Loss of Power 113 487
Unintended System Motion 87 478
Electrical /Electronic Property Problem 80 245
Mechanical Jam 79 245
Grounding Malfunction 56 147
Mechanical Problem 44 105
Fluid/Blood Leak 26 150
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
Unintended Electrical Shock 2 2
Fire 2 2
Battery Problem 1 1
Incorrect Measurement 1 1
Loss of or Failure to Bond 1 1
No Apparent Adverse Event 1 1
Smoking 1 1
Component Missing 1 1
No Audible Alarm 1 1
Leak/Splash 1 1
Arcing 1 1
Output Problem 1 1
Positioning Problem 1 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 356 1404
No Patient Involvement 135 535
Insufficient Information 38 55
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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