TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	409	412
Break	328	343
Pressure Problem	294	323
Crack	100	100
Insufficient Flow or Under Infusion	68	68
No Flow	45	45
Device Alarm System	39	39
Gas/Air Leak	31	31
Output Problem	22	22
Detachment of Device or Device Component	21	21
Incorrect, Inadequate or Imprecise Result or Readings	19	19
No Audible Alarm	19	19
Fracture	18	18
Device Sensing Problem	16	16
Mechanical Problem	15	15
Nonstandard Device	14	14
Microbial Contamination of Device	10	10
Device Damaged Prior to Use	9	9
Contamination	8	8
Product Quality Problem	7	7
Electrical /Electronic Property Problem	7	7
Infusion or Flow Problem	6	6
Therapeutic or Diagnostic Output Failure	6	6
Excessive Heating	6	6
Smoking	6	6
Melted	6	6
Loose or Intermittent Connection	6	6
Insufficient Information	5	5
Overheating of Device	5	5
Gas Output Problem	5	5
Unable to Obtain Readings	5	5
Defective Alarm	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Insufficient Heating	4	4
Device Dislodged or Dislocated	4	4
Fire	4	4
No Apparent Adverse Event	4	4
Loss of or Failure to Bond	4	4
Unexpected Therapeutic Results	3	3
Power Problem	3	3
Electrical Shorting	3	3
Circuit Failure	3	3
Lack of Maintenance Documentation or Guidelines	2	2
Protective Measures Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Temperature Problem	2	2
Noise, Audible	2	2
Structural Problem	2	2
Material Fragmentation	2	2
Defective Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1198	1244
Insufficient Information	260	260
Alteration in Body Temperature	12	12
Hyperthermia	9	9
Low Oxygen Saturation	7	7
Fall	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Hypothermia	3	3
Superficial (First Degree) Burn	2	2
Skull Fracture	2	2
Burn(s)	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