TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	1972	1972
Break	197	197
Pressure Problem	130	130
Crack	103	103
Insufficient Flow or Under Infusion	52	52
Device Alarm System	39	39
Nonstandard Device	32	32
Output Problem	21	21
Gas/Air Leak	21	21
No Audible Alarm	20	20
Incorrect, Inadequate or Imprecise Result or Readings	20	20
Fracture	18	18
Mechanical Problem	15	15
Detachment of Device or Device Component	14	14
Device Sensing Problem	12	12
Therapeutic or Diagnostic Output Failure	12	12
Microbial Contamination of Device	10	10
Product Quality Problem	8	8
Electrical /Electronic Property Problem	8	8
Contamination	8	8
Device Damaged Prior to Use	7	7
No Flow	6	6
Melted	6	6
Overheating of Device	6	6
Smoking	6	6
Defective Alarm	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Excessive Heating	4	4
Unable to Obtain Readings	4	4
Insufficient Information	4	4
Fire	4	4
Loss of or Failure to Bond	4	4
Unexpected Therapeutic Results	3	3
Loose or Intermittent Connection	3	3
Power Problem	3	3
Thermal Decomposition of Device	3	3
Infusion or Flow Problem	3	3
No Apparent Adverse Event	3	3
Electrical Shorting	3	3
Temperature Problem	3	3
Circuit Failure	3	3
Lack of Maintenance Documentation or Guidelines	2	2
Insufficient Heating	2	2
Gas Output Problem	2	2
Appropriate Term/Code Not Available	2	2
Protective Measures Problem	2	2
Device Dislodged or Dislocated	2	2
Improper or Incorrect Procedure or Method	2	2
Device Displays Incorrect Message	2	2
Noise, Audible	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	1188	1188
No Clinical Signs, Symptoms or Conditions	1131	1131
Insufficient Information	327	327
No Known Impact Or Consequence To Patient	28	28
Alteration in Body Temperature	10	10
Fall	6	6
Burn(s)	4	4
Hyperthermia	4	4
Skull Fracture	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
No Consequences Or Impact To Patient	2	2
Fungal Infection	1	1
Bone Fracture(s)	1	1
Fever	1	1
Hypothermia	1	1
Bradycardia	1	1
Hemorrhage/Bleeding	1	1
Respiratory Insufficiency	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	Wipro GE Healthcare Private Ltd.	II	Sep-20-2024