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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 664 3222

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 897 3755
Mechanical Problem 743 2395
Device Fell 443 761
Positioning Failure 366 1187
Unintended Movement 345 394
Difficult or Delayed Positioning 319 2939
Sharp Edges 283 938
Fluid/Blood Leak 248 2330
Device Slipped 219 600
Device Tipped Over 196 309
Difficult to Remove 101 317
Protective Measures Problem 91 206
Device Dislodged or Dislocated 82 185
Electrical /Electronic Property Problem 80 482
Grounding Malfunction 71 227
Unstable 64 87
Positioning Problem 60 97
Patient Device Interaction Problem 54 58
Adverse Event Without Identified Device or Use Problem 38 38
Break 25 25
No Apparent Adverse Event 21 21
Insufficient Information 21 21
Detachment of Device or Device Component 18 19
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 8 8
Fail-Safe Did Not Operate 8 31
Defective Component 8 8
Fire 7 7
Component Missing 7 10
Mechanics Altered 6 6
Therapeutic or Diagnostic Output Failure 6 6
Material Integrity Problem 6 6
Intermittent Loss of Power 6 8
Battery Problem 5 5
No Audible Alarm 5 8
Corroded 5 5
Improper or Incorrect Procedure or Method 5 5
Material Deformation 5 5
Material Split, Cut or Torn 5 5
Unintended Collision 5 5
Fail-Safe Problem 4 5
Defective Device 4 4
Naturally Worn 3 3
Complete Loss of Power 3 3
Component Incompatible 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 2970 12491
No Patient Involvement 980 4307
Insufficient Information 286 426
Pain 148 565
No Consequences Or Impact To Patient 105 524
Injury 59 59
Laceration(s) 53 69
Fall 49 310
Muscle/Tendon Damage 38 71
Abrasion 38 82
Bruise/Contusion 32 216
Bone Fracture(s) 30 30
Head Injury 16 18
No Known Impact Or Consequence To Patient 14 14
Unspecified Tissue Injury 12 12
Unspecified Musculoskeletal problem 10 107
Hematoma 10 14
Death 5 5
Hemorrhage/Bleeding 5 5
Sprain 5 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Swelling/ Edema 4 7
Crushing Injury 4 4
Spinal Column Injury 4 4
Limb Fracture 3 3
Discomfort 3 12
Swelling 3 5
Tissue Damage 3 3
Skin Tears 3 3
No Information 3 3
Headache 3 5
Deformity/ Disfigurement 3 3
Inflammation 2 2
Hip Fracture 2 2
Uterine Perforation 2 2
Nodule 1 1
Anxiety 1 1
Shock 1 1
Aneurysm 1 1
Unspecified Heart Problem 1 1
Reaction 1 1
Physical Entrapment 1 1
Eye Injury 1 1
Intervertebral Disc Compression or Protrusion 1 1
Pressure Sores 1 1
Extubate 1 1
Internal Organ Perforation 1 1
Tissue Breakdown 1 1
Numbness 1 1
Concussion 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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