TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	400	403
Break	384	399
Pressure Problem	352	381
Crack	98	98
Insufficient Flow or Under Infusion	69	69
No Flow	60	60
Gas/Air Leak	39	39
Device Alarm System	36	36
Device Sensing Problem	32	32
Detachment of Device or Device Component	28	28
No Audible Alarm	19	19
Mechanical Problem	18	18
Fracture	18	18
Incorrect, Inadequate or Imprecise Result or Readings	17	17
Output Problem	16	16
Physical Resistance/Sticking	13	13
Microbial Contamination of Device	10	10
Electrical /Electronic Property Problem	9	9
Device Damaged Prior to Use	9	9
Adverse Event Without Identified Device or Use Problem	7	7
Loose or Intermittent Connection	6	6
Infusion or Flow Problem	6	6
Gas Output Problem	5	5
Excessive Heating	5	5
No Apparent Adverse Event	5	5
Insufficient Device Problem Information	5	5
Loss of or Failure to Bond	4	4
Insufficient Heating	4	4
Device Dislodged or Dislocated	4	4
Unable to Obtain Readings	4	4
Unexpected Therapeutic Results	3	3
Defective Alarm	3	3
Electrical Shorting	3	3
Fire	3	3
Circuit Failure	3	3
Obstruction of Flow	2	2
Material Fragmentation	2	2
Structural Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Failure to Sense	2	2
Device Fell	2	2
Power Problem	2	2
Suction Failure	2	2
Melted	2	2
Overheating of Device	2	2
Temperature Problem	2	2
No Pressure	1	1
Degraded	1	1
Patient Device Interaction Problem	1	1
Contamination /Decontamination Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1367	1413
Insufficient Information	260	260
Alteration in Body Temperature	12	12
Hyperthermia	9	9
Low Oxygen Saturation	8	8
Fall	5	5
Hypothermia	3	3
Pressure Sore/Ulcer	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Superficial (First Degree) Burn	2	2
Skull Fracture	2	2
Skin Inflammation/ Irritation	2	2
Burn(s)	2	2
Rash	2	2
Bruise/Contusion	2	2
Pneumothorax	1	1
Fungal Infection	1	1
Bone Fracture(s)	1	1
Fever	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Laceration(s)	1	1
Bradycardia	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	Datex-Ohmeda Inc	I	Jun-18-2026
2	Draeger Medical Systems, Inc.	II	Jun-22-2023
3	Wipro GE Healthcare Private Ltd.	II	Sep-20-2024