TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Positioning Failure	1751	1751
Loss of or Failure to Bond	244	244
Separation Failure	129	129
Failure to Transmit Record	112	112
Detachment of Device or Device Component	108	108
Entrapment of Device	47	47
Insufficient Information	28	28
Adverse Event Without Identified Device or Use Problem	20	20
Break	16	16
Activation, Positioning or Separation Problem	15	15
Unintended Application Program Shut Down	15	15
Difficult or Delayed Separation	14	14
Activation Problem	11	11
Loss of Data	9	9
Premature Separation	8	8
Activation Failure	8	8
Material Twisted/Bent	6	6
Malposition of Device	4	4
Device Damaged Prior to Use	4	4
Defective Device	4	4
Therapeutic or Diagnostic Output Failure	4	4
Data Problem	4	4
Unexpected Shutdown	3	3
Physical Resistance/Sticking	3	3
Device Dislodged or Dislocated	3	3
Failure to Advance	3	3
Migration	3	3
Use of Device Problem	3	3
Loss of Power	2	2
Loose or Intermittent Connection	2	2
Connection Problem	2	2
Nonstandard Device	2	2
Failure to Fire	2	2
Calibration Problem	2	2
Blocked Connection	2	2
Failure to Power Up	2	2
Patient Device Interaction Problem	2	2
Difficult to Remove	2	2
Material Integrity Problem	2	2
Unintended Movement	2	2
Mechanical Problem	2	2
Device Slipped	2	2
Misfire	1	1
Unable to Obtain Readings	1	1
Component Missing	1	1
Failure to Align	1	1
Material Fragmentation	1	1
Key or Button Unresponsive/not Working	1	1
Mechanics Altered	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	914	914
No Consequences Or Impact To Patient	550	550
Foreign Body In Patient	404	404
Airway Obstruction	344	344
Insufficient Information	66	66
Aspiration/Inhalation	55	55
Injury	36	36
Pain	29	29
Chest Pain	26	26
Hemorrhage/Bleeding	23	23
Unintended Radiation Exposure	23	23
Laceration(s) of Esophagus	23	23
Sedation	17	17
Oversedation	17	17
Cough	14	14
No Information	12	12
Sore Throat	11	11
Failure of Implant	10	10
No Known Impact Or Consequence To Patient	10	10
Discomfort	9	9
Laceration(s)	8	8
No Code Available	8	8
Dysphagia/ Odynophagia	8	8
Unspecified Tissue Injury	8	8
Radiation Exposure, Unintended	6	6
Blood Loss	5	5
Vomiting	5	5
Dyspnea	4	4
Low Oxygen Saturation	3	3
Ulcer	3	3
Cramp(s) /Muscle Spasm(s)	2	2
Asthma	2	2
No Patient Involvement	2	2
Perforation of Esophagus	2	2
Nausea	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Low Blood Pressure/ Hypotension	1	1
Respiratory Insufficiency	1	1
Arthritis	1	1
Device Embedded In Tissue or Plaque	1	1
Constipation	1	1
Distress	1	1
Hypoxia	1	1
Tissue Damage	1	1
Swelling/ Edema	1	1
Bradycardia	1	1
Nasal Obstruction	1	1
Respiratory Tract Infection	1	1
Burning Sensation	1	1
Fever	1	1