TPLC - Total Product Life Cycle

• Device: alarm, conditioned response enuresis
• Product Code: KPN
• 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
Vibration	22	22
Thermal Decomposition of Device	22	22
Noise, Audible	16	16
Material Twisted/Bent	15	15
Melted	15	15
Electrical Shorting	14	14
Patient-Device Incompatibility	12	12
Battery Problem	11	11
Device Alarm System	11	11
Smoking	9	9
Scratched Material	8	8
Malposition of Device	7	7
Detachment of Device or Device Component	7	7
Material Deformation	6	6
Material Protrusion/Extrusion	6	6
Unintended Electrical Shock	6	6
Fluid/Blood Leak	6	6
Display or Visual Feedback Problem	6	6
Burst Container or Vessel	5	5
Fire	5	5
Product Quality Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Explosion	4	4
Physical Resistance/Sticking	4	4
Device Fell	4	4
Excessive Heating	4	4
Device Dislodged or Dislocated	4	4
Unstable	4	4
Material Rupture	3	3
Defective Alarm	3	3
Electrical /Electronic Property Problem	3	3
Deformation Due to Compressive Stress	3	3
Failure to Shut Off	3	3
Therapeutic or Diagnostic Output Failure	3	3
Protective Measures Problem	2	2
Failure to Power Up	2	2
Loose or Intermittent Connection	2	2
Mechanical Problem	2	2
Circuit Failure	2	2
Crack	2	2
Self-Activation or Keying	2	2
Difficult to Remove	2	2
Moisture Damage	2	2
Loss of Power	1	1
No Audible Prompt/Feedback	1	1
Use of Device Problem	1	1
Degraded	1	1
Erratic or Intermittent Display	1	1
No Audible Alarm	1	1
Premature Discharge of Battery	1	1
False Alarm	1	1
Material Fragmentation	1	1
Gel Leak	1	1
Entrapment of Device	1	1
Unintended Ejection	1	1
Material Integrity Problem	1	1
Gas/Air Leak	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Electrical Power Problem	1	1
Device-Device Incompatibility	1	1
Difficult to Open or Close	1	1
Appropriate Term/Code Not Available	1	1
Unexpected Shutdown	1	1

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
Rash	14	14
Laceration(s)	14	14
Swelling	11	11
No Information	10	10
Choking	9	9
Shock	9	9
Skin Irritation	9	9
Blood Loss	8	8
No Patient Involvement	8	8
Superficial (First Degree) Burn	8	8
Shock from Patient Lead(s)	7	7
Partial thickness (Second Degree) Burn	6	6
Chemical Exposure	6	6
Bruise/Contusion	6	6
Discomfort	6	6
Burning Sensation	5	5
Hemorrhage/Bleeding	5	5
No Code Available	5	5
Emotional Changes	4	4
Tissue Damage	4	4
No Consequences Or Impact To Patient	4	4
Skin Inflammation	4	4
Skin Discoloration	3	3
Reaction	3	3
Device Embedded In Tissue or Plaque	2	2
Foreign Body In Patient	2	2
Strangulation	2	2
Irritation	2	2
Itching Sensation	2	2
Eye Injury	2	2
Sweating	2	2
Sleep Dysfunction	2	2
Tingling	2	2
Therapeutic Response, Decreased	1	1
Complaint, Ill-Defined	1	1
Eye Burn	1	1
Skin Tears	1	1
Needle Stick/Puncture	1	1
Depression	1	1
Fatigue	1	1
Abrasion	1	1
Dyspnea	1	1
Non specific EKG/ECG Changes	1	1
Scar Tissue	1	1
Patient Problem/Medical Problem	1	1
Alteration In Body Temperature	1	1

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