TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure To Adhere Or Bond	1928	1928
Positioning Failure	1914	1914
Loss of or Failure to Bond	804	804
Detachment of Device or Device Component	237	237
Failure to Transmit Record	161	161
Communication or Transmission Problem	159	159
Device Operates Differently Than Expected	133	133
Detachment Of Device Component	114	114
Entrapment of Device	110	110
Adverse Event Without Identified Device or Use Problem	90	90
Separation Failure	82	82
Unintended Application Program Shut Down	62	62
Connection Problem	56	56
Insufficient Information	55	55
Difficult or Delayed Positioning	40	40
Signal Artifact/Noise	31	31
Device Displays Incorrect Message	31	31
High pH	30	30
Activation, Positioning or Separation Problem	24	24
Loss of Data	21	21
Break	21	21
Data Problem	20	20
Missing Test Results	20	20
Failure to Calibrate	16	16
Failure to Power Up	15	15
Loss of Power	15	15
Activation Problem	15	15
Difficult or Delayed Separation	12	12
Poor Quality Image	12	12
Calibration Problem	9	9
Appropriate Term/Code Not Available	9	9
Misconnection	9	9
Activation Failure	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Malposition of Device	8	8
Loose or Intermittent Connection	7	7
Difficult to Remove	7	7
Defective Device	6	6
Material Twisted/Bent	6	6
Failure to Disconnect	6	6
Failure to Advance	6	6
No Display/Image	6	6
Mechanical Problem	6	6
Noise, Audible	5	5
Device Slipped	5	5
Positioning Problem	5	5
Invalid Sensing	5	5
Device Fell	5	5
High Readings	5	5
Physical Resistance/Sticking	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	2386	2386
No Known Impact Or Consequence To Patient	1580	1580
No Clinical Signs, Symptoms or Conditions	744	744
Foreign Body In Patient	312	312
Airway Obstruction	279	279
No Information	96	96
Aspiration/Inhalation	67	67
Chest Pain	64	64
Insufficient Information	58	58
Radiation Exposure, Unintended	56	56
Pain	56	56
No Code Available	49	49
Injury	45	45
No Patient Involvement	38	38
Laceration(s) of Esophagus	28	28
Unintended Radiation Exposure	23	23
Hemorrhage/Bleeding	19	19
Discomfort	19	19
Oversedation	17	17
Sedation	17	17
Cough	12	12
Tissue Damage	11	11
Dysphagia/ Odynophagia	9	9
Failure of Implant	9	9
Blood Loss	9	9
Vomiting	9	9
Sore Throat	9	9
Unspecified Tissue Injury	8	8
Ulcer	7	7
Inflammation	5	5
Dyspnea	5	5
Nausea	5	5
Abdominal Pain	5	5
Perforation	4	4
Laceration(s)	4	4
Hypoxia	4	4
Death	4	4
Fever	4	4
Low Oxygen Saturation	4	4
Ulceration	3	3
Reaction	3	3
Perforation of Esophagus	3	3
Device Embedded In Tissue or Plaque	2	2
Foreign Body Sensation in Eye	2	2
Asthma	2	2
Pyrosis/Heartburn	2	2
Swelling	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Choking	2	2
Collapse	2	2