TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Biocompatibility	69	69
Incorrect, Inadequate or Imprecise Result or Readings	16	16
Communication or Transmission Problem	12	13
Connection Problem	7	7
Overheating of Device	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Fracture	4	4
Mechanical Problem	3	3
Device Contaminated During Manufacture or Shipping	2	2
Fire	2	2
Thermal Decomposition of Device	2	2
Delivered as Unsterile Product	2	2
Detachment of Device or Device Component	2	2
Incorrect Interpretation of Signal	2	2
Disconnection	1	1
Failure to Read Input Signal	1	1
Sparking	1	1
Break	1	1
Failure to Sense	1	2
High Readings	1	1
Gas/Air Leak	1	1
Imprecise or Erratic Results	1	1
Optical Problem	1	1
Packaging Problem	1	1
Failure to Capture	1	1
Labelling, Instructions for Use or Training Problem	1	1
Incorrect Measurement	1	1
Product Quality Problem	1	1
Low Readings	1	1
No Apparent Adverse Event	1	1
Melted	1	1
False Positive Result	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	76	77
Skin Inflammation/ Irritation	66	66
Insufficient Information	7	7
Blister	4	4
Skin Burning Sensation	4	4
Unspecified Infection	2	2
Syncope/Fainting	2	2
Skin Infection	2	2
Arrhythmia	2	3
Fluid Discharge	2	2
Loss of consciousness	2	2
Burning Sensation	1	1
Nerve Damage	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Pain	1	1
Peeling	1	1
Limb Fracture	1	1
Anxiety	1	1
Hypoxia	1	1
Heart Block	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ad-Tech Medical Instrument Corporation	II	Sep-20-2021
2	Stryker Sustainability Solutions	II	Aug-20-2024