TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Positioning Failure	1431	1431
Separation Failure	293	293
Failure to Transmit Record	106	106
Entrapment of Device	43	43
Detachment of Device or Device Component	42	42
Insufficient Information	33	33
Adverse Event Without Identified Device or Use Problem	24	24
Break	21	21
Difficult or Delayed Separation	19	19
Activation, Positioning or Separation Problem	17	17
Activation Failure	14	15
Unintended Application Program Shut Down	9	9
Activation Problem	7	7
Premature Separation	5	5
Device Dislodged or Dislocated	5	5
Loss of Data	5	5
Loss of or Failure to Bond	5	5
Nonstandard Device	5	7
Device Damaged Prior to Use	5	5
Defective Device	4	4
Mechanical Problem	4	4
Use of Device Problem	4	4
Material Twisted/Bent	3	3
Therapeutic or Diagnostic Output Failure	3	3
Patient Device Interaction Problem	3	3
Migration	3	3
Failure to Fire	3	3
Malposition of Device	2	2
Blocked Connection	2	2
Calibration Problem	2	2
Defective Component	2	2
Difficult to Remove	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Failure to Power Up	2	2
Physical Resistance/Sticking	2	2
Device Fell	2	2
Unexpected Shutdown	2	2
Unintended Movement	2	2
Material Integrity Problem	2	2
Display or Visual Feedback Problem	2	2
Human-Device Interface Problem	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Difficult to Open or Remove Packaging Material	1	1
Improper or Incorrect Procedure or Method	1	1
Suction Problem	1	2
Mechanics Altered	1	1
No Apparent Adverse Event	1	1
Problem with Software Installation	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	970	973
Foreign Body In Patient	541	541
Airway Obstruction	410	410
Insufficient Information	61	61
Aspiration/Inhalation	39	39
Hemorrhage/Bleeding	35	35
Laceration(s) of Esophagus	32	32
Chest Pain	31	31
Pain	30	30
Unintended Radiation Exposure	17	17
Cough	16	16
Sore Throat	15	15
Oversedation	11	11
Discomfort	11	11
Dysphagia/ Odynophagia	10	10
Failure of Implant	8	8
Unspecified Tissue Injury	6	6
Laceration(s)	6	6
Low Oxygen Saturation	5	5
Vomiting	5	5
Distress	4	4
Ulcer	3	3
Fever	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Pyrosis/Heartburn	2	2
Asthma	2	2
Perforation of Esophagus	2	2
Nausea	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Neck Pain	1	1
Burning Sensation	1	1
Numbness	1	1
Dyspnea	1	1
Bradycardia	1	1
Gastrointestinal Regurgitation	1	1
Valvular Insufficiency/ Regurgitation	1	1
Malaise	1	1
Swelling/ Edema	1	1
Inflammation	1	1
Hypoxia	1	1
Bowel Perforation	1	1
Dizziness	1	1
Bacterial Infection	1	1
Headache	1	1
Constipation	1	1
Respiratory Insufficiency	1	1
Arthritis	1	1
Low Blood Pressure/ Hypotension	1	1
Apnea	1	1
Lethargy	1	1