TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Erratic or Intermittent Display	676	676
No Display/Image	458	458
Display or Visual Feedback Problem	444	444
Optical Problem	189	189
Poor Quality Image	145	145
Break	106	106
Electrical /Electronic Property Problem	78	78
Use of Device Problem	46	46
Connection Problem	45	45
Image Display Error/Artifact	44	44
Loose or Intermittent Connection	35	35
Insufficient Information	31	31
Device Handling Problem	23	23
Failure to Power Up	22	22
Mechanical Problem	20	20
Material Erosion	16	16
Output Problem	15	15
Appropriate Term/Code Not Available	15	15
Intermittent Loss of Power	14	14
Defective Device	14	14
Therapeutic or Diagnostic Output Failure	13	13
Adverse Event Without Identified Device or Use Problem	13	13
Material Opacification	12	12
Battery Problem	11	11
Fitting Problem	11	11
Material Separation	11	11
Detachment of Device or Device Component	10	10
Activation Failure	10	10
Temperature Problem	9	9
Failure to Run on Battery	8	8
Material Fragmentation	8	8
Defective Component	7	7
Electrical Shorting	6	6
Power Problem	6	6
No Visual Prompts/Feedback	6	6
Intermittent Continuity	6	6
Display Difficult to Read	5	5
Device Reprocessing Problem	5	5
Device-Device Incompatibility	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Application Program Freezes, Becomes Nonfunctional	4	4
Material Deformation	4	4
Environmental Compatibility Problem	4	4
Sharp Edges	4	4
Overheating of Device	4	4
Continuous Firing	4	4
Patient Device Interaction Problem	4	4
Disconnection	4	4
Unexpected Shutdown	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1439	1439
No Consequences Or Impact To Patient	241	241
Insufficient Information	236	236
No Patient Involvement	75	75
No Known Impact Or Consequence To Patient	63	63
Unspecified Tissue Injury	18	18
Low Oxygen Saturation	16	16
Cardiac Arrest	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Laceration(s)	10	10
Hemorrhage/Bleeding	6	6
Foreign Body In Patient	6	6
Aspiration/Inhalation	4	4
Hypoxia	4	4
Bradycardia	4	4
Death	3	3
Airway Obstruction	3	3
Respiratory Arrest	3	3
Tooth Fracture	3	3
Abrasion	3	3
Injury	3	3
Unspecified Respiratory Problem	3	3
Respiratory Distress	2	2
Burn(s)	2	2
Skin Tears	2	2
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Unintended Extubation	1	1
Tinnitus	1	1
Extubate	1	1
Shock	1	1
Swelling/ Edema	1	1
Asystole	1	1
Choking	1	1
Cardiopulmonary Arrest	1	1
Vomiting	1	1
Laceration(s) of Esophagus	1	1
Crushing Injury	1	1
Obstruction/Occlusion	1	1
Exsanguination	1	1
Perforation	1	1
No Information	1	1
Acoustic Shock	1	1
No Code Available	1	1
Hypoventilation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Jun-24-2022
2	Covidien	II	Aug-22-2024
3	Covidien	I	Aug-21-2024
4	Covidien	I	Nov-02-2023
5	Covidien	II	Nov-01-2023
6	Flexicare Medical Ltd.	II	Jan-13-2020
7	Karl Storz Endoscopy	II	Dec-18-2023
8	King Systems Corp. dba Ambu, Inc.	I	Feb-04-2020
9	Medtronic, PLC	II	Feb-10-2020
10	TELEFLEX MEDICAL INC	II	Mar-23-2021
11	TELEFLEX MEDICAL INC	II	Jul-28-2020
12	TELEFLEX MEDICAL INC	II	Feb-07-2020
13	Verathon, Inc.	II	Jun-04-2024
14	Verathon, Inc.	III	Jul-30-2021
15	Verathon, Inc.	I	Jul-10-2020
16	Verathon, Inc.	II	Mar-11-2020