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	349	364
Pressure Problem	322	351
Crack	112	112
Insufficient Flow or Under Infusion	68	68
No Flow	47	47
Device Alarm System	40	40
Gas/Air Leak	35	35
Nonstandard Device	32	32
No Audible Alarm	27	27
Detachment of Device or Device Component	24	24
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	11	11
Microbial Contamination of Device	10	10
Device Damaged Prior to Use	9	9
Loose or Intermittent Connection	8	8
Product Quality Problem	8	8
Contamination	8	8
Infusion or Flow Problem	7	7
Excessive Heating	7	7
Overheating of Device	6	6
Physical Resistance/Sticking	6	6
Melted	6	6
Smoking	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Unable to Obtain Readings	5	5
Defective Alarm	5	5
Insufficient Information	5	5
Fire	5	5
Gas Output 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
Electrical Shorting	3	3
Power Problem	3	3
Unexpected Therapeutic Results	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
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	1563	1609
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	8	8
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