TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	1972	1975
Break	317	332
Pressure Problem	278	307
Crack	111	111
Insufficient Flow or Under Infusion	66	66
No Flow	42	42
Device Alarm System	40	40
Nonstandard Device	32	32
Gas/Air Leak	31	31
No Audible Alarm	26	26
Detachment of Device or Device Component	22	22
Output Problem	22	22
Mechanical Problem	19	19
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Fracture	18	18
Device Sensing Problem	17	17
Therapeutic or Diagnostic Output Failure	12	12
Electrical /Electronic Property Problem	10	10
Microbial Contamination of Device	10	10
Device Damaged Prior to Use	9	9
Product Quality Problem	8	8
Contamination	8	8
Excessive Heating	7	7
Smoking	6	6
Melted	6	6
Overheating of Device	6	6
Loose or Intermittent Connection	6	6
Defective Alarm	5	5
Insufficient Information	5	5
Fire	5	5
Gas Output Problem	5	5
Unable to Obtain Readings	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Infusion or Flow Problem	5	5
Device Dislodged or Dislocated	4	4
No Apparent Adverse Event	4	4
Insufficient Heating	4	4
Loss of or Failure to Bond	4	4
Power Problem	3	3
Unexpected Therapeutic Results	3	3
Electrical Shorting	3	3
Temperature Problem	3	3
Thermal Decomposition of Device	3	3
Circuit Failure	3	3
Noise, Audible	2	2
Structural Problem	2	2
Device Displays Incorrect Message	2	2
Improper or Incorrect Procedure or Method	2	2
Device Handling Problem	2	2
Lack of Maintenance Documentation or Guidelines	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1474	1520
No Patient Involvement	1188	1188
Insufficient Information	329	329
No Known Impact Or Consequence To Patient	28	28
Alteration in Body Temperature	12	12
Hyperthermia	9	9
Low Oxygen Saturation	7	7
Fall	6	6
Burn(s)	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Skull Fracture	3	3
Hypothermia	3	3
Superficial (First Degree) Burn	2	2
Inadequate Osseointegration	2	2
No Consequences Or Impact To Patient	2	2
Bruise/Contusion	2	2
Pneumothorax	1	1
Fungal Infection	1	1
Bone Fracture(s)	1	1
Fever	1	1
Laceration(s)	1	1
Bradycardia	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	Wipro GE Healthcare Private Ltd.	II	Sep-20-2024