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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stretcher, wheeled
Regulation Description Wheeled stretcher.
Product CodeFPO
Regulation Number 880.6910
Device Class 2

MDR Year MDR Reports MDR Events
2020 694 2702
2021 874 2467
2022 694 2687
2023 1028 3614
2024 956 4278
2025 214 1101

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 799 3237
Mechanical Problem 653 1750
Unintended Movement 401 401
Device Fell 395 656
Positioning Failure 378 1406
Difficult or Delayed Positioning 322 3080
Fluid/Blood Leak 298 2769
Sharp Edges 271 958
Device Slipped 201 630
Device Tipped Over 167 250
Difficult to Remove 115 340
Protective Measures Problem 99 230
Device Dislodged or Dislocated 87 205
Electrical /Electronic Property Problem 85 577
Grounding Malfunction 70 258
Patient Device Interaction Problem 56 60
Unstable 55 72
Positioning Problem 32 32
Adverse Event Without Identified Device or Use Problem 28 28
Break 27 27
No Apparent Adverse Event 21 21
Insufficient Information 21 21
Patient-Device Incompatibility 16 17
Loose or Intermittent Connection 11 11
Detachment of Device or Device Component 10 10
Physical Resistance/Sticking 8 8
Use of Device Problem 8 8
Fail-Safe Did Not Operate 7 7
Material Split, Cut or Torn 7 7
Fire 7 7
Material Integrity Problem 6 6
Defective Component 6 6
Intermittent Loss of Power 6 8
No Audible Alarm 5 8
Battery Problem 5 5
Mechanics Altered 5 5
Material Deformation 5 5
Collapse 5 5
Unintended System Motion 5 5
Corroded 5 5
Fail-Safe Problem 4 5
Therapeutic or Diagnostic Output Failure 4 4
Component Missing 4 4
Degraded 3 3
Incorrect Measurement 3 3
Material Separation 3 3
Power Problem 3 3
Appropriate Term/Code Not Available 3 3
Naturally Worn 3 3
Complete Loss of Power 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3445 14617
No Patient Involvement 454 1947
Insufficient Information 301 446
Pain 133 511
Laceration(s) 53 69
No Consequences Or Impact To Patient 44 303
Muscle/Tendon Damage 40 73
Fall 39 449
Abrasion 35 66
Bruise/Contusion 28 212
Bone Fracture(s) 25 25
Injury 19 19
Unspecified Tissue Injury 12 12
Head Injury 11 13
Hematoma 11 15
Unspecified Musculoskeletal problem 10 107
No Known Impact Or Consequence To Patient 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Hemorrhage/Bleeding 4 4
Swelling/ Edema 4 7
Sprain 4 6
Deformity/ Disfigurement 3 3
Headache 3 5
Skin Tears 3 3
Limb Fracture 3 3
Shock 2 80
Discomfort 2 4
Uterine Perforation 2 2
Death 2 2
Spinal Column Injury 2 2
Crushing Injury 2 2
Hip Fracture 2 2
Inflammation 2 2
No Information 2 2
Tissue Breakdown 1 1
Ventilator Dependent 1 1
Internal Organ Perforation 1 1
Pressure Sores 1 1
Abdominal Pain 1 1
Hearing Impairment 1 1
Damage to Ligament(s) 1 1
Intervertebral Disc Compression or Protrusion 1 1
Unspecified Heart Problem 1 1
Tissue Damage 1 1
Aneurysm 1 1
Nodule 1 1
Anxiety 1 1
Tingling 1 1
Brain Injury 1 1
Shock from Patient Lead(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ferno-Washington Inc II Nov-04-2022
2 Linet Spol. S.r.o. II Mar-04-2023
3 Stryker Medical Division of Stryker Corporation II Jul-12-2023
4 Stryker Medical Division of Stryker Corporation II Mar-15-2023
5 Stryker Medical Division of Stryker Corporation II Dec-14-2022
6 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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