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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alarm, conditioned response enuresis
Product CodeKPN
Regulation Number 876.2040
Device Class 2

MDR Year MDR Reports MDR Events
2019 423 423
2020 36 36
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 266 266
Leak/Splash 64 64
Device Emits Odor 58 58
Temperature Problem 54 54
Defective Component 36 36
Break 33 33
Defective Device 29 29
Inappropriate/Inadequate Shock/Stimulation 27 27
Thermal Decomposition of Device 22 22
Vibration 22 22
Noise, Audible 16 16
Material Twisted/Bent 15 15
Melted 15 15
Electrical Shorting 14 14
Patient-Device Incompatibility 12 12
Device Alarm System 11 11
Battery Problem 11 11
Smoking 9 9
Scratched Material 8 8
Detachment of Device or Device Component 7 7
Malposition of Device 7 7
Material Deformation 6 6
Material Protrusion/Extrusion 6 6
Unintended Electrical Shock 6 6
Display or Visual Feedback Problem 6 6
Fluid/Blood Leak 6 6
Fire 5 5
Burst Container or Vessel 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Product Quality Problem 5 5
Device Fell 4 4
Excessive Heating 4 4
Device Dislodged or Dislocated 4 4
Explosion 4 4
Physical Resistance/Sticking 4 4
Unstable 4 4
Therapeutic or Diagnostic Output Failure 3 3
Defective Alarm 3 3
Electrical /Electronic Property Problem 3 3
Deformation Due to Compressive Stress 3 3
Material Rupture 3 3
Failure to Shut Off 3 3
Self-Activation or Keying 2 2
Protective Measures Problem 2 2
Loose or Intermittent Connection 2 2
Failure to Power Up 2 2
Difficult to Remove 2 2
Moisture Damage 2 2
Crack 2 2
Mechanical Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 153 153
No Known Impact Or Consequence To Patient 126 126
Pain 56 56
Injury 26 26
Electric Shock 24 24
Scarring 18 18
Burn(s) 18 18
Erythema 16 16
Laceration(s) 14 14
Rash 14 14
Swelling 11 11
No Information 10 10
Shock 9 9
Skin Irritation 9 9
Choking 9 9
Superficial (First Degree) Burn 8 8
Blood Loss 8 8
No Patient Involvement 8 8
Shock from Patient Lead(s) 7 7
Bruise/Contusion 6 6
Partial thickness (Second Degree) Burn 6 6
Chemical Exposure 6 6
Discomfort 6 6
Hemorrhage/Bleeding 5 5
No Code Available 5 5
Burning Sensation 5 5
No Consequences Or Impact To Patient 4 4
Tissue Damage 4 4
Emotional Changes 4 4
Skin Inflammation 4 4
Reaction 3 3
Skin Discoloration 3 3
Device Embedded In Tissue or Plaque 2 2
Eye Injury 2 2
Strangulation 2 2
Foreign Body In Patient 2 2
Irritation 2 2
Itching Sensation 2 2
Sweating 2 2
Tingling 2 2
Sleep Dysfunction 2 2
Depression 1 1
Needle Stick/Puncture 1 1
Dyspnea 1 1
Alteration In Body Temperature 1 1
Scar Tissue 1 1
Eye Burn 1 1
Abrasion 1 1
Fatigue 1 1
Therapeutic Response, Decreased 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Oct-31-2022
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