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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 2688
2023 1028 3615
2024 956 4282
2025 890 3960

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 858 3470
Mechanical Problem 697 1828
Unintended Movement 591 591
Device Fell 441 756
Positioning Failure 428 1882
Difficult or Delayed Positioning 368 3826
Fluid/Blood Leak 325 2999
Sharp Edges 316 1154
Device Slipped 228 734
Device Tipped Over 175 260
Difficult to Remove 133 412
Protective Measures Problem 120 315
Device Dislodged or Dislocated 105 252
Electrical /Electronic Property Problem 100 745
Grounding Malfunction 79 329
Unstable 62 87
Patient Device Interaction Problem 58 62
Adverse Event Without Identified Device or Use Problem 34 34
Detachment of Device or Device Component 33 33
Positioning Problem 32 32
Break 27 27
Insufficient Information 22 22
No Apparent Adverse Event 21 21
Patient-Device Incompatibility 16 17
Fire 13 13
Loose or Intermittent Connection 12 12
Material Split, Cut or Torn 11 11
Collapse 10 10
Use of Device Problem 10 10
Physical Resistance/Sticking 8 8
Fail-Safe Did Not Operate 7 7
No Audible Alarm 7 11
Battery Problem 7 7
Material Integrity Problem 6 7
Defective Component 6 6
Mechanics Altered 6 6
Intermittent Loss of Power 6 8
Defective Device 5 5
Unintended System Motion 5 5
Corroded 5 5
Power Problem 5 5
Material Deformation 5 5
Component Missing 4 4
Fail-Safe Problem 4 5
Therapeutic or Diagnostic Output Failure 4 4
Output Problem 4 4
Incorrect Measurement 3 3
Material Separation 3 3
Degraded 3 3
Appropriate Term/Code Not Available 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4081 17441
No Patient Involvement 454 1947
Insufficient Information 326 545
Pain 140 545
Laceration(s) 62 91
Muscle/Tendon Damage 45 346
Fall 44 465
No Consequences Or Impact To Patient 44 303
Abrasion 40 73
Bruise/Contusion 31 215
Bone Fracture(s) 25 25
Injury 19 19
Unspecified Tissue Injury 13 13
Unspecified Musculoskeletal problem 12 112
Hematoma 12 16
Head Injury 12 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Known Impact Or Consequence To Patient 6 6
Hemorrhage/Bleeding 5 5
Swelling/ Edema 4 7
Skin Tears 4 13
Sprain 4 6
Electric Shock 4 121
Headache 3 5
Deformity/ Disfigurement 3 3
Discomfort 3 129
Limb Fracture 3 3
Inflammation 2 2
Muscle Weakness 2 4
Crushing Injury 2 2
No Information 2 2
Spinal Column Injury 2 2
Neck Pain 2 2
Shock 2 78
Hip Fracture 2 2
Numbness 2 4
Death 2 2
Uterine Perforation 2 2
Intervertebral Disc Compression or Protrusion 1 1
Unspecified Heart Problem 1 1
Aneurysm 1 1
Tissue Damage 1 1
Pressure Sores 1 1
Anxiety 1 1
Tissue Breakdown 1 1
Nodule 1 1
Internal Organ Perforation 1 1
Ventilator Dependent 1 1
Distress 1 1
Physical Entrapment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ferno-Washington Inc II Oct-10-2025
2 Ferno-Washington Inc II Nov-04-2022
3 Linet Spol. S.r.o. II Mar-04-2023
4 Stryker Medical Division of Stryker Corporation II Jul-12-2023
5 Stryker Medical Division of Stryker Corporation II Mar-15-2023
6 Stryker Medical Division of Stryker Corporation II Dec-14-2022
7 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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