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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


Premarket Reviews
ManufacturerDecision
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM CO.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRANSMOTION MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WINCO MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
WINCO MFG., LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 88 88
2015 4 4
2016 5 5
2017 5 5
2018 63 146
2019 79 328
2020 89 295
2021 114 308
2022 93 393
2023 147 527
2024 80 385

Device Problems MDRs with this Device Problem Events in those MDRs
Intermittent Loss of Power 130 550
Unintended System Motion 99 553
Mechanical Jam 94 295
Electrical /Electronic Property Problem 94 294
Grounding Malfunction 66 175
Mechanical Problem 61 152
Break 48 48
Device Slipped 38 41
Positioning Problem 32 34
Unintended Movement 31 88
Fluid/Blood Leak 30 196
Sharp Edges 27 39
Device Stops Intermittently 18 21
Positioning Failure 16 18
Device Inoperable 13 13
Device Fell 12 12
Insufficient Information 11 11
Device Operates Differently Than Expected 8 8
Adverse Event Without Identified Device or Use Problem 5 5
Naturally Worn 5 5
Patient Device Interaction Problem 5 5
Defective Component 5 5
Scratched Material 3 3
Sticking 2 2
No Audible Alarm 2 2
Unintended Electrical Shock 2 2
Peeled/Delaminated 2 2
Fire 2 2
Improper or Incorrect Procedure or Method 2 2
Malposition of Device 1 1
Crack 1 1
Physical Resistance/Sticking 1 1
Migration or Expulsion of Device 1 1
Communication or Transmission Problem 1 1
Output Problem 1 1
Kinked 1 1
Defective Device 1 1
Leak/Splash 1 1
Smoking 1 1
Material Integrity Problem 1 1
Loose or Intermittent Connection 1 1
Arcing 1 1
False Reading From Device Non-Compliance 1 1
Battery Problem 1 1
Loss of Power 1 1
Connection Problem 1 1
Bent 1 1
Failure to Align 1 1
Material Separation 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 407 1654
No Patient Involvement 188 670
No Known Impact Or Consequence To Patient 84 86
Insufficient Information 40 65
Pain 19 26
Injury 17 17
Muscle/Tendon Damage 10 34
No Consequences Or Impact To Patient 9 21
Laceration(s) 8 8
Fall 7 11
Electric Shock 6 12
Bruise/Contusion 5 20
Bone Fracture(s) 2 2
Shock 2 4
Joint Dislocation 1 1
Fatigue 1 1
No Code Available 1 1
Sprain 1 1
No Information 1 1
Unspecified Musculoskeletal problem 1 4
Head Injury 1 1
Neck Pain 1 1
Muscle Spasm(s) 1 1
Concussion 1 1
Discomfort 1 5
Physical Entrapment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Div. of Stryker Corporation II Aug-09-2010
2 Stryker Medical Division of Stryker Corporation II Jun-01-2020
3 Stryker Medical Division of Stryker Corporation II Mar-17-2016
4 Stryker Medical Division of Stryker Corporation II Aug-03-2011
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