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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 215 1064

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 823 3365
Mechanical Problem 692 2293
Device Fell 402 686
Positioning Failure 335 945
Unintended Movement 295 344
Difficult or Delayed Positioning 287 2538
Sharp Edges 248 831
Device Slipped 201 554
Fluid/Blood Leak 188 1750
Device Tipped Over 187 298
Difficult to Remove 86 289
Protective Measures Problem 82 189
Device Dislodged or Dislocated 72 172
Electrical /Electronic Property Problem 68 411
Grounding Malfunction 65 200
Positioning Problem 60 97
Unstable 58 80
Patient Device Interaction Problem 48 52
Adverse Event Without Identified Device or Use Problem 32 32
Break 24 24
Insufficient Information 21 21
Detachment of Device or Device Component 18 19
No Apparent Adverse Event 17 17
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
Defective Component 8 8
Physical Resistance/Sticking 8 8
Fail-Safe Did Not Operate 8 31
Component Missing 7 10
Fire 7 7
Therapeutic or Diagnostic Output Failure 6 6
Mechanics Altered 6 6
Material Integrity Problem 6 6
Intermittent Loss of Power 6 8
Battery Problem 5 5
Material Deformation 5 5
Improper or Incorrect Procedure or Method 5 5
Corroded 5 5
Unintended Collision 4 4
Defective Device 4 4
Fail-Safe Problem 4 5
Material Twisted/Bent 3 3
Naturally Worn 3 3
Power Problem 3 3
Appropriate Term/Code Not Available 3 3
Material Separation 3 3
Degraded 3 3
Component Incompatible 3 3
No Audible Alarm 3 4
Incorrect Measurement 3 3
Complete Loss of Power 3 3
Activation Problem 2 2
Fracture 2 2
Leak/Splash 2 2
Output Problem 2 2
Activation Failure 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Human-Device Interface Problem 1 2
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Sparking 1 1
Energy Output Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Self-Activation or Keying 1 1
Sensing Intermittently 1 1
Inaccurate Delivery 1 1
Failure to Align 1 1
Arcing 1 1
Vibration 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Misassembled 1 1
Misconnection 1 1
Misassembled During Installation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2568 10380
No Patient Involvement 980 4307
Insufficient Information 266 378
Pain 138 554
No Consequences Or Impact To Patient 105 524
Injury 59 59
Fall 47 308
Laceration(s) 45 60
Abrasion 33 76
Muscle/Tendon Damage 30 63
Bone Fracture(s) 27 27
Bruise/Contusion 26 41
Head Injury 14 16
No Known Impact Or Consequence To Patient 14 14
Unspecified Tissue Injury 12 12
Hematoma 10 14
Unspecified Musculoskeletal problem 9 105
Sprain 5 14
Hemorrhage/Bleeding 5 5
Death 5 5
Swelling/ Edema 4 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Spinal Column Injury 4 4
Limb Fracture 3 3
Discomfort 3 12
Skin Tears 3 3
No Information 3 3
Crushing Injury 3 3
Headache 3 5
Swelling 3 5
Tissue Damage 3 3
Uterine Perforation 2 2
Hip Fracture 2 2
Inflammation 2 2
Damage to Ligament(s) 1 1
Muscle Weakness 1 1
Hearing Impairment 1 1
Abdominal Pain 1 1
Eye Injury 1 1
Contusion 1 1
Aneurysm 1 1
Deformity/ Disfigurement 1 1
Extubate 1 1
Reaction 1 1
Numbness 1 1
Neck Pain 1 1
Needle Stick/Puncture 1 1
Tingling 1 1
Concussion 1 1
Dizziness 1 1
Retinal Injury 1 1
Seizures 1 1
Skull Fracture 1 1
Movement Disorder 1 1
Unspecified Blood or Lymphatic problem 1 1
Unspecified Heart Problem 1 1
Epistaxis 1 1
Shock from Patient Lead(s) 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 1 1
Confusion/ Disorientation 1 1
Complaint, Ill-Defined 1 1
Strangulation 1 1
Brain Injury 1 1
Intervertebral Disc Compression or Protrusion 1 1
Nodule 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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