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	304	319
Pressure Problem	266	295
Crack	97	97
Insufficient Flow or Under Infusion	64	64
No Flow	41	41
Device Alarm System	39	39
Gas/Air Leak	28	28
Output Problem	22	22
No Audible Alarm	19	19
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Detachment of Device or Device Component	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
Electrical /Electronic Property Problem	7	7
Product Quality Problem	7	7
Smoking	6	6
Melted	6	6
Loose or Intermittent Connection	6	6
Excessive Heating	6	6
Therapeutic or Diagnostic Output Failure	6	6
Gas Output Problem	5	5
Defective Alarm	5	5
Unable to Obtain Readings	5	5
Overheating of Device	5	5
Insufficient Information	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Fire	4	4
Loss of or Failure to Bond	4	4
Insufficient Heating	4	4
No Apparent Adverse Event	4	4
Infusion or Flow Problem	4	4
Device Dislodged or Dislocated	4	4
Power Problem	3	3
Unexpected Therapeutic Results	3	3
Electrical Shorting	3	3
Circuit Failure	3	3
Protective Measures Problem	2	2
Temperature Problem	2	2
Failure to Sense	2	2
Material Fragmentation	2	2
Improper or Incorrect Procedure or Method	2	2
Noise, Audible	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Suction Failure	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1134	1180
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