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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 167 562

Device Problems MDRs with this Device Problem Events in those MDRs
Intermittent Loss of Power 127 553
Unintended System Motion 102 588
Electrical /Electronic Property Problem 94 304
Mechanical Jam 88 276
Grounding Malfunction 65 182
Mechanical Problem 48 110
Fluid/Blood Leak 34 208
Sharp Edges 28 40
Positioning Failure 16 18
Unintended Movement 15 61
Device Fell 12 12
Device Slipped 11 14
Insufficient Information 7 7
Break 6 6
Patient Device Interaction Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Defective Component 3 3
Fire 2 2
Unintended Electrical Shock 2 2
No Audible Alarm 2 2
Leak/Splash 1 1
Output Problem 1 1
Smoking 1 1
Positioning Problem 1 3
Battery Problem 1 1
Component Missing 1 1
Incorrect Measurement 1 1
No Apparent Adverse Event 1 1
Arcing 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 464 1801
No Patient Involvement 135 535
Insufficient Information 69 94
Pain 18 25
Muscle/Tendon Damage 10 34
Fall 6 10
Electric Shock 5 11
Laceration(s) 5 5
No Consequences Or Impact To Patient 4 14
Injury 3 3
Bruise/Contusion 3 18
Bone Fracture(s) 2 2
Shock 2 4
Joint Dislocation 1 1
Fatigue 1 1
Unspecified Musculoskeletal problem 1 4
Neck Pain 1 1
Concussion 1 1
Discomfort 1 5

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