TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	3337	3411
Break	170	170
Crack	118	118
Pressure Problem	58	58
Device Alarm System	37	37
Nonstandard Device	34	34
Electrical /Electronic Property Problem	33	33
Insufficient Flow or Under Infusion	24	24
Output Problem	22	22
Incorrect, Inadequate or Imprecise Result or Readings	20	20
Fracture	18	18
No Audible Alarm	17	17
Mechanical Problem	17	17
Detachment of Device or Device Component	16	16
Gas/Air Leak	16	16
Material Discolored	15	15
Therapeutic or Diagnostic Output Failure	12	12
Microbial Contamination of Device	10	10
Device Sensing Problem	9	9
Contamination	8	8
Product Quality Problem	8	8
Melted	6	6
Smoking	6	6
Overheating of Device	6	6
Protective Measures Problem	6	7
Device Damaged Prior to Use	5	5
Defective Alarm	5	5
Appropriate Term/Code Not Available	5	5
Excessive Heating	4	4
Loss of or Failure to Bond	4	4
Thermal Decomposition of Device	4	4
Fire	4	4
Unable to Obtain Readings	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Temperature Problem	4	4
Power Problem	3	3
No Apparent Adverse Event	3	3
No Flow	3	3
Device Dislodged or Dislocated	3	3
Electrical Shorting	3	3
Device Displays Incorrect Message	3	3
Loose or Intermittent Connection	3	3
Improper or Incorrect Procedure or Method	3	3
Unexpected Therapeutic Results	3	3
Circuit Failure	3	3
Device Fell	3	3
Device Handling Problem	2	2
Use of Device Problem	2	2
Failure to Sense	2	2
Insufficient Heating	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	2583	2658
No Clinical Signs, Symptoms or Conditions	963	963
Insufficient Information	324	324
No Known Impact Or Consequence To Patient	51	51
No Consequences Or Impact To Patient	15	15
Alteration in Body Temperature	10	10
Fall	7	7
Skull Fracture	5	5
Burn(s)	3	3
Low Oxygen Saturation	3	3
Superficial (First Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Inadequate Osseointegration	2	2
Death	1	1
Fungal Infection	1	1
Bone Fracture(s)	1	1
Hematoma	1	1
Edema	1	1
Fever	1	1
Injury	1	1
Swelling	1	1
Hypothermia	1	1
Bradycardia	1	1
Hyperthermia	1	1
Partial thickness (Second Degree) Burn	1	1
Hemorrhage/Bleeding	1	1
Thromboembolism	1	1
Full thickness (Third Degree) Burn	1	1
Bruise/Contusion	1	1
External Prosthetic Device Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Draeger Medical Systems, Inc.	II	Jun-22-2023
2	GE Healthcare, LLC	I	Dec-03-2019
3	GE Healthcare, LLC	I	Jul-11-2019
4	Wipro GE Healthcare Private Ltd.	II	Sep-20-2024