TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	1120	1120
Erratic or Intermittent Display	746	746
Display or Visual Feedback Problem	527	527
Optical Problem	369	369
Poor Quality Image	204	204
Electrical /Electronic Property Problem	113	113
Break	111	111
Device Reprocessing Problem	70	70
Image Display Error/Artifact	54	54
Failure to Power Up	52	52
Use of Device Problem	50	50
Connection Problem	46	46
Mechanical Problem	41	41
Output Problem	41	41
Failure to Run on Battery	40	40
Loose or Intermittent Connection	40	40
Insufficient Information	34	34
Device Handling Problem	23	23
Material Opacification	20	20
Material Erosion	19	19
Detachment of Device or Device Component	17	17
Material Separation	16	16
Appropriate Term/Code Not Available	15	15
Intermittent Loss of Power	14	14
Defective Device	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Therapeutic or Diagnostic Output Failure	13	13
Battery Problem	11	11
Fitting Problem	11	11
Device Damaged Prior to Use	10	10
Activation Failure	10	10
Material Fragmentation	9	9
Temperature Problem	9	9
Manufacturing, Packaging or Shipping Problem	8	8
Material Integrity Problem	8	8
Intermittent Continuity	7	7
Defective Component	7	7
No Visual Prompts/Feedback	7	7
Power Problem	7	7
Mechanical Jam	7	7
Electrical Shorting	6	6
Material Deformation	6	6
Overheating of Device	5	5
Display Difficult to Read	5	5
Crack	5	5
Physical Resistance/Sticking	5	5
Unexpected Shutdown	5	5
Improper or Incorrect Procedure or Method	5	5
Device-Device Incompatibility	5	5
Naturally Worn	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2350	2350
Insufficient Information	363	363
No Consequences Or Impact To Patient	241	241
No Patient Involvement	75	75
No Known Impact Or Consequence To Patient	63	63
Low Oxygen Saturation	19	19
Unspecified Tissue Injury	19	19
Cardiac Arrest	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Laceration(s)	10	10
Foreign Body In Patient	8	8
Hemorrhage/Bleeding	7	7
Unspecified Respiratory Problem	5	5
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
Respiratory Insufficiency	2	2
Skin Tears	2	2
Swelling/ Edema	2	2
Burn(s)	2	2
Respiratory Distress	2	2
High Oxygen Saturation	2	2
Vomiting	1	1
Cardiopulmonary Arrest	1	1
Laceration(s) of Esophagus	1	1
Choking	1	1
Pain	1	1
Crushing Injury	1	1
Asystole	1	1
Obstruction/Occlusion	1	1
Exsanguination	1	1
Shock	1	1
Cough	1	1
Perforation	1	1
No Information	1	1
Adult Respiratory Distress Syndrome	1	1
Acoustic Shock	1	1
Extubate	1	1
No Code Available	1	1
Tinnitus	1	1
Sore Throat	1	1
Unintended Extubation	1	1
Low Blood Pressure/ Hypotension	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	Intersurgical Inc	I	Jul-11-2025
8	Karl Storz Endoscopy	II	Dec-18-2023
9	King Systems Corp. dba Ambu, Inc.	I	Feb-04-2020
10	Medtronic, PLC	II	Feb-10-2020
11	TELEFLEX MEDICAL INC	II	Mar-23-2021
12	TELEFLEX MEDICAL INC	II	Jul-28-2020
13	TELEFLEX MEDICAL INC	II	Feb-07-2020
14	Verathon, Inc.	II	Jun-04-2024
15	Verathon, Inc.	III	Jul-30-2021
16	Verathon, Inc.	I	Jul-10-2020
17	Verathon, Inc.	II	Mar-11-2020