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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
Regulation Description Powered wheeled stretcher.
Product CodeINK
Regulation Number 890.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
WINCO MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 5 5
2017 5 5
2018 63 146
2019 79 328
2020 89 295
2021 60 148

Device Problems MDRs with this Device Problem Events in those MDRs
Intermittent Loss of Power 62 246
Mechanical Jam 46 156
Electrical /Electronic Property Problem 36 85
Mechanical Problem 35 118
Unintended System Motion 31 133
Unintended Movement 30 87
Grounding Malfunction 29 60
Sharp Edges 13 20
Device Stops Intermittently 5 8
Device Fell 4 4
Device Operates Differently Than Expected 4 4
Positioning Failure 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Peeled/Delaminated 2 2
Device Slipped 2 2
Use of Device Problem 1 1
Failure to Align 1 1
Migration or Expulsion of Device 1 1
No Audible Alarm 1 1
Break 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Leak/Splash 1 1
Device Inoperable 1 1
Arcing 1 1
Material Integrity Problem 1 1
Positioning Problem 1 3
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 188 670
No Clinical Signs, Symptoms or Conditions 87 243
Injury 13 13
No Consequences Or Impact To Patient 7 19
Pain 6 10
Fall 3 3
No Known Impact Or Consequence To Patient 2 4
Bruise/Contusion 2 5
Laceration(s) 2 2
Bone Fracture(s) 1 1
Head Injury 1 1
Shock 1 3
Discomfort 1 5
Electric Shock 1 1
No Information 1 1
No Code Available 1 1
Muscle/Tendon Damage 1 1
Insufficient Information 1 1
Muscle Spasm(s) 1 1
Sprain 1 1
Neck Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Division of Stryker Corporation II Jun-01-2020
2 Stryker Medical Division of Stryker Corporation II Mar-17-2016
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