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	284	299
Pressure Problem	245	274
Crack	108	108
Insufficient Flow or Under Infusion	62	62
Device Alarm System	40	40
No Flow	38	38
Nonstandard Device	32	32
Gas/Air Leak	28	28
No Audible Alarm	26	26
Output Problem	22	22
Detachment of Device or Device Component	19	19
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Mechanical Problem	18	18
Fracture	18	18
Device Sensing Problem	14	14
Therapeutic or Diagnostic Output Failure	12	12
Microbial Contamination of Device	10	10
Device Damaged Prior to Use	9	9
Product Quality Problem	8	8
Electrical /Electronic Property Problem	8	8
Contamination	8	8
Excessive Heating	7	7
Loose or Intermittent Connection	6	6
Overheating of Device	6	6
Smoking	6	6
Melted	6	6
Fire	5	5
Infusion or Flow Problem	5	5
Insufficient Information	5	5
Unable to Obtain Readings	5	5
Defective Alarm	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Loss of or Failure to Bond	4	4
Gas Output Problem	4	4
Insufficient Heating	4	4
No Apparent Adverse Event	4	4
Electrical Shorting	3	3
Thermal Decomposition of Device	3	3
Device Dislodged or Dislocated	3	3
Power Problem	3	3
Unexpected Therapeutic Results	3	3
Temperature Problem	3	3
Circuit Failure	3	3
Protective Measures Problem	2	2
Appropriate Term/Code Not Available	2	2
Lack of Maintenance Documentation or Guidelines	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 Clinical Signs, Symptoms or Conditions	1397	1443
No Patient Involvement	1188	1188
Insufficient Information	328	328
No Known Impact Or Consequence To Patient	28	28
Alteration in Body Temperature	12	12
Hyperthermia	7	7
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
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