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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
2020 694 2702
2021 874 2467
2022 694 2687
2023 1028 3614
2024 955 4277

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 776 3135
Mechanical Problem 643 1733
Device Fell 383 631
Positioning Failure 357 1267
Unintended Movement 352 352
Difficult or Delayed Positioning 309 2835
Fluid/Blood Leak 274 2523
Sharp Edges 258 907
Device Slipped 190 572
Device Tipped Over 164 247
Difficult to Remove 105 324
Protective Measures Problem 94 217
Device Dislodged or Dislocated 80 182
Electrical /Electronic Property Problem 78 489
Grounding Malfunction 66 232
Unstable 54 69
Patient Device Interaction Problem 53 57
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
Fire 7 7
Material Split, Cut or Torn 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 3244 13529
No Patient Involvement 454 1947
Insufficient Information 293 433
Pain 130 508
Laceration(s) 51 67
No Consequences Or Impact To Patient 44 303
Muscle/Tendon Damage 40 73
Fall 37 298
Abrasion 34 65
Bruise/Contusion 28 212
Bone Fracture(s) 24 24
Injury 19 19
Unspecified Tissue Injury 12 12
Hematoma 11 15
Head Injury 11 13
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
Swelling/ Edema 4 7
Sprain 4 6
Hemorrhage/Bleeding 4 4
Limb Fracture 3 3
Headache 3 5
Deformity/ Disfigurement 3 3
Crushing Injury 2 2
Inflammation 2 2
Spinal Column Injury 2 2
Skin Tears 2 2
No Information 2 2
Discomfort 2 4
Hip Fracture 2 2
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
Shock 1 1
Anxiety 1 1
Nodule 1 1
Pressure Sores 1 1
Physical Entrapment 1 1
Eye Injury 1 1
Tissue Breakdown 1 1
Internal Organ Perforation 1 1
Ventilator Dependent 1 1
Strangulation 1 1
Numbness 1 1
Concussion 1 1
Swelling 1 3

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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