TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	3337	3414
Break	321	336
Pressure Problem	266	295
Crack	130	130
Insufficient Flow or Under Infusion	64	64
Device Alarm System	43	43
No Flow	41	41
Electrical /Electronic Property Problem	35	35
Nonstandard Device	34	34
No Audible Alarm	30	30
Gas/Air Leak	28	28
Detachment of Device or Device Component	26	26
Output Problem	23	23
Mechanical Problem	21	21
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Fracture	18	18
Device Sensing Problem	17	17
Material Discolored	15	15
Therapeutic or Diagnostic Output Failure	12	12
Microbial Contamination of Device	10	10
Device Damaged Prior to Use	9	9
Contamination	8	8
Product Quality Problem	8	8
Excessive Heating	7	7
Overheating of Device	6	6
Melted	6	6
Smoking	6	6
Loose or Intermittent Connection	6	6
Protective Measures Problem	6	7
Insufficient Information	5	5
Gas Output Problem	5	5
Fire	5	5
Appropriate Term/Code Not Available	5	5
Loss of or Failure to Bond	5	5
Infusion or Flow Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Device Dislodged or Dislocated	5	5
Unable to Obtain Readings	5	5
Defective Alarm	5	5
No Apparent Adverse Event	5	5
Thermal Decomposition of Device	4	4
Insufficient Heating	4	4
Temperature Problem	4	4
Power Problem	3	3
Electrical Shorting	3	3
Unexpected Therapeutic Results	3	3
Improper or Incorrect Procedure or Method	3	3
Device Displays Incorrect Message	3	3
Circuit Failure	3	3
Lack of Maintenance Documentation or Guidelines	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	2583	2658
No Clinical Signs, Symptoms or Conditions	1447	1493
Insufficient Information	329	329
No Known Impact Or Consequence To Patient	51	51
No Consequences Or Impact To Patient	15	15
Alteration in Body Temperature	12	12
Hyperthermia	9	9
Fall	7	7
Low Oxygen Saturation	7	7
Skull Fracture	5	5
Burn(s)	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Hypothermia	3	3
Superficial (First Degree) Burn	2	2
Inadequate Osseointegration	2	2
Bruise/Contusion	2	2
Death	1	1
Pneumothorax	1	1
Fungal Infection	1	1
Hematoma	1	1
Bone Fracture(s)	1	1
Edema	1	1
Injury	1	1
Fever	1	1
Swelling	1	1
Laceration(s)	1	1
Bradycardia	1	1
Partial thickness (Second Degree) Burn	1	1
Thromboembolism	1	1
Hemorrhage/Bleeding	1	1
Respiratory Insufficiency	1	1
Full thickness (Third Degree) Burn	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