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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2019 663 2549
2020 694 2702
2021 874 2467
2022 694 2687
2023 1028 3614
2024 923 4250

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 935 3960
Mechanical Problem 767 2429
Device Fell 463 795
Unintended Movement 383 432
Positioning Failure 381 1311
Difficult or Delayed Positioning 335 3121
Sharp Edges 294 993
Fluid/Blood Leak 273 2523
Device Slipped 227 624
Device Tipped Over 202 314
Difficult to Remove 109 331
Protective Measures Problem 94 217
Electrical /Electronic Property Problem 87 532
Device Dislodged or Dislocated 85 188
Grounding Malfunction 75 254
Unstable 65 89
Positioning Problem 60 97
Patient Device Interaction Problem 56 60
Adverse Event Without Identified Device or Use Problem 41 41
Break 33 33
No Apparent Adverse Event 21 21
Insufficient Information 21 21
Detachment of Device or Device Component 19 20
Patient-Device Incompatibility 16 17
Loose or Intermittent Connection 13 13
Use of Device Problem 11 11
Unintended System Motion 10 44
Collapse 9 9
Physical Resistance/Sticking 9 9
Defective Component 8 8
Fail-Safe Did Not Operate 8 31
Fire 7 7
Component Missing 7 10
Intermittent Loss of Power 7 9
Material Integrity Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Mechanics Altered 6 6
Corroded 5 5
No Audible Alarm 5 8
Improper or Incorrect Procedure or Method 5 5
Battery Problem 5 5
Material Deformation 5 5
Material Split, Cut or Torn 5 5
Unintended Collision 5 5
Material Twisted/Bent 4 4
Fail-Safe Problem 4 5
Defective Device 4 4
Incorrect Measurement 3 3
Material Separation 3 3
Degraded 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3215 13505
No Patient Involvement 980 4307
Insufficient Information 293 433
Pain 153 570
No Consequences Or Impact To Patient 105 524
Injury 59 59
Laceration(s) 54 70
Fall 49 310
Abrasion 40 86
Muscle/Tendon Damage 39 72
Bruise/Contusion 34 219
Bone Fracture(s) 31 31
Head Injury 16 18
No Known Impact Or Consequence To Patient 14 14
Unspecified Tissue Injury 12 12
Hematoma 12 16
Unspecified Musculoskeletal problem 10 107
Sprain 5 14
Hemorrhage/Bleeding 5 5
Death 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Crushing Injury 4 4
Spinal Column Injury 4 4
Swelling/ Edema 4 7
No Information 3 3
Headache 3 5
Deformity/ Disfigurement 3 3
Skin Tears 3 3
Tissue Damage 3 3
Swelling 3 5
Discomfort 3 12
Limb Fracture 3 3
Inflammation 2 2
Hip Fracture 2 2
Uterine Perforation 2 2
Intervertebral Disc Compression or Protrusion 1 1
Unspecified Heart Problem 1 1
Aneurysm 1 1
Pressure Sores 1 1
Nodule 1 1
Anxiety 1 1
Shock 1 1
Extubate 1 1
Reaction 1 1
Physical Entrapment 1 1
Eye Injury 1 1
Internal Organ Perforation 1 1
Ventilator Dependent 1 1
Tissue Breakdown 1 1
Numbness 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
7 Stryker Medical Division of Stryker Corporation II May-15-2019
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