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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


Premarket Reviews
ManufacturerDecision
SIMAVITA PTY LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 9 9
2016 21 21
2017 185 185
2018 286 286
2019 423 423
2020 36 36
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 551 551
Leak/Splash 240 240
Temperature Problem 156 156
Melted 108 108
Burst Container or Vessel 71 71
Device Emits Odor 61 61
Noise, Audible 61 61
Defective Component 52 52
Electrical Shorting 47 47
Defective Device 43 43
Break 40 40
Inappropriate/Inadequate Shock/Stimulation 33 33
Vibration 31 31
Device Operates Differently Than Expected 28 28
Thermal Decomposition of Device 27 27
Material Deformation 27 27
Fluid/Blood Leak 25 25
Battery Problem 22 22
Material Twisted/Bent 22 22
Chemical Spillage 21 21
Device Alarm System 15 15
Smoking 14 14
Product Quality Problem 14 14
Patient-Device Incompatibility 13 13
Adverse Event Without Identified Device or Use Problem 10 10
Device Displays Incorrect Message 9 9
Fire 9 9
Display or Visual Feedback Problem 8 8
Scratched Material 8 8
Bent 7 7
Malposition of Device 7 7
Detachment of Device or Device Component 7 7
Fumes or Vapors 6 6
Material Rupture 6 6
Use of Device Problem 6 6
Detachment Of Device Component 6 6
Material Protrusion/Extrusion 6 6
Unintended Electrical Shock 6 6
Insufficient Information 5 5
Protective Measures Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Defective Alarm 5 5
No Audible Alarm 5 5
Circuit Failure 5 5
Loss of Power 5 5
Improper or Incorrect Procedure or Method 5 5
Deformation Due to Compressive Stress 5 5
Device Dislodged or Dislocated 4 4
Device Inoperable 4 4
Unstable 4 4
Mechanical Problem 4 4
Failure to Shut Off 4 4
Explosion 4 4
Physical Resistance/Sticking 4 4
Device Fell 4 4
Excessive Heating 4 4
Gas/Air Leak 3 3
Therapeutic or Diagnostic Output Failure 3 3
Loose or Intermittent Connection 3 3
Material Disintegration 3 3
Premature Discharge of Battery 3 3
Component Falling 3 3
Electrical /Electronic Property Problem 3 3
Device Unsafe to Use in Environment 3 3
Structural Problem 2 2
Self-Activation or Keying 2 2
Difficult to Remove 2 2
Crack 2 2
Unintended Ejection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Radiation Leak 2 2
Failure to Power Up 2 2
Moisture Damage 2 2
Material Integrity Problem 2 2
Expulsion 2 2
Device Contamination with Chemical or Other Material 1 1
Mechanical Jam 1 1
No Fail-Safe Mechanism 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Shutdown 1 1
Nonstandard Device 1 1
Material Fragmentation 1 1
Gel Leak 1 1
Erratic or Intermittent Display 1 1
Degraded 1 1
Disconnection 1 1
Corroded 1 1
Entrapment of Device 1 1
Fail-Safe Design Failure 1 1
False Alarm 1 1
Material Separation 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
No Audible Prompt/Feedback 1 1
Failure to Osseointegrate 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Electrical Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 330 330
No Known Impact Or Consequence To Patient 189 189
Pain 110 110
Burn(s) 96 96
Caustic/Chemical Burns 49 49
Injury 45 45
Erythema 44 44
Scarring 43 43
Rash 29 29
Electric Shock 29 29
No Information 28 28
Chemical Exposure 27 27
Choking 22 22
Swelling 22 22
Bruise/Contusion 21 21
No Code Available 20 20
Partial thickness (Second Degree) Burn 17 17
No Patient Involvement 17 17
Discomfort 17 17
Superficial (First Degree) Burn 16 16
Laceration(s) 15 15
Skin Irritation 13 13
Burning Sensation 12 12
No Consequences Or Impact To Patient 11 11
Reaction 11 11
Shock 10 10
Blood Loss 9 9
Irritation 8 8
Scar Tissue 7 7
Tissue Damage 7 7
Shock from Patient Lead(s) 7 7
Foreign Body In Patient 6 6
Emotional Changes 6 6
Hemorrhage/Bleeding 6 6
Skin Inflammation 4 4
Depression 4 4
Complaint, Ill-Defined 3 3
Sleep Dysfunction 3 4
Device Embedded In Tissue or Plaque 3 3
Tingling 3 3
Skin Discoloration 3 3
Strangulation 2 2
Therapeutic Response, Decreased 2 2
Hypersensitivity/Allergic reaction 2 2
Eye Injury 2 2
Itching Sensation 2 2
Sweating 2 2
Needle Stick/Puncture 1 1
Obstruction/Occlusion 1 1
Toxicity 1 1
Eye Burn 1 1
Skin Tears 1 1
Patient Problem/Medical Problem 1 1
Alteration In Body Temperature 1 1
Myocardial Infarction 1 1
Fatigue 1 1
Abrasion 1 1
Exsanguination 1 1
Death 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Anxiety 1 1
Shock, Traumatic 1 1
Vomiting 1 1
Peeling 1 1
Perforation 1 1

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