TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	1070	1070
Erratic or Intermittent Display	721	721
Display or Visual Feedback Problem	488	488
Optical Problem	288	288
Poor Quality Image	161	161
Break	108	108
Electrical /Electronic Property Problem	95	95
Image Display Error/Artifact	53	53
Failure to Power Up	52	52
Use of Device Problem	49	49
Connection Problem	46	46
Mechanical Problem	40	40
Failure to Run on Battery	39	39
Loose or Intermittent Connection	37	37
Insufficient Information	34	34
Device Reprocessing Problem	27	27
Device Handling Problem	23	23
Output Problem	19	19
Material Opacification	18	18
Material Erosion	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
Detachment of Device or Device Component	13	13
Battery Problem	11	11
Fitting Problem	11	11
Activation Failure	10	10
Device Damaged Prior to Use	10	10
Temperature Problem	9	9
Manufacturing, Packaging or Shipping Problem	8	8
Material Fragmentation	8	8
Defective Component	7	7
Power Problem	6	6
Intermittent Continuity	6	6
Electrical Shorting	6	6
No Visual Prompts/Feedback	6	6
Material Integrity Problem	6	6
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
Application Program Freezes, Becomes Nonfunctional	4	4
Naturally Worn	4	4
Overheating of Device	4	4
Material Deformation	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2162	2162
Insufficient Information	333	333
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	18	18
Cardiac Arrest	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Laceration(s)	10	10
Hemorrhage/Bleeding	7	7
Foreign Body In Patient	7	7
Aspiration/Inhalation	4	4
Hypoxia	4	4
Bradycardia	4	4
Death	3	3
Respiratory Arrest	3	3
Airway Obstruction	3	3
Abrasion	3	3
Tooth Fracture	3	3
Injury	3	3
Unspecified Respiratory Problem	3	3
High Oxygen Saturation	2	2
Respiratory Distress	2	2
Burn(s)	2	2
Skin Tears	2	2
Swelling/ Edema	2	2
Unintended Extubation	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Insufficiency	1	1
Extubate	1	1
Tinnitus	1	1
Shock	1	1
Asystole	1	1
Choking	1	1
Pain	1	1
Cardiopulmonary Arrest	1	1
Vomiting	1	1
Obstruction/Occlusion	1	1
Laceration(s) of Esophagus	1	1
Crushing Injury	1	1
Perforation	1	1
Exsanguination	1	1
No Information	1	1
No Code Available	1	1
Adult Respiratory Distress Syndrome	1	1
Acoustic Shock	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