TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Positioning Failure	1491	1491
Loss of or Failure to Bond	644	644
Detachment of Device or Device Component	171	171
Failure to Transmit Record	110	110
Separation Failure	69	69
Entrapment of Device	67	67
Unintended Application Program Shut Down	47	47
Insufficient Information	45	45
Adverse Event Without Identified Device or Use Problem	35	35
Signal Artifact/Noise	18	18
Activation, Positioning or Separation Problem	16	16
Activation Problem	15	15
Break	14	14
Difficult or Delayed Separation	12	12
Loss of Power	11	11
Loss of Data	11	11
Activation Failure	8	8
Data Problem	8	8
Failure to Power Up	8	8
Material Twisted/Bent	6	6
Failure to Advance	5	5
High pH	5	5
Malposition of Device	5	5
Defective Device	4	4
Therapeutic or Diagnostic Output Failure	4	4
Calibration Problem	4	4
Poor Quality Image	4	4
Premature Separation	4	4
Connection Problem	3	3
Unexpected Shutdown	3	3
Physical Resistance/Sticking	3	3
Low pH	3	3
Use of Device Problem	3	3
Failure to Calibrate	3	3
Device Dislodged or Dislocated	3	3
Separation Problem	2	2
Material Integrity Problem	2	2
Device Slipped	2	2
Noise, Audible	2	2
Migration	2	2
Device Alarm System	2	2
Failure to Fire	2	2
Difficult to Remove	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Blocked Connection	2	2
Patient Device Interaction Problem	2	2
No Display/Image	2	2
Migration or Expulsion of Device	2	2
Loose or Intermittent Connection	2	2
Mechanical Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	1030	1030
No Clinical Signs, Symptoms or Conditions	744	744
Foreign Body In Patient	295	295
Airway Obstruction	279	279
No Information	69	69
Insufficient Information	58	58
Aspiration/Inhalation	55	55
Injury	39	39
Chest Pain	38	38
No Known Impact Or Consequence To Patient	36	36
Pain	32	32
Laceration(s) of Esophagus	24	24
Unintended Radiation Exposure	23	23
Radiation Exposure, Unintended	22	22
Sedation	17	17
No Code Available	17	17
Oversedation	17	17
Hemorrhage/Bleeding	13	13
Cough	12	12
Discomfort	10	10
Failure of Implant	9	9
Unspecified Tissue Injury	8	8
Blood Loss	8	8
Sore Throat	8	8
Tissue Damage	6	6
Vomiting	6	6
Dysphagia/ Odynophagia	6	6
Dyspnea	5	5
Ulcer	4	4
Nausea	4	4
Laceration(s)	4	4
Inflammation	3	3
No Patient Involvement	3	3
Pyrosis/Heartburn	2	2
Asthma	2	2
Fever	2	2
Hypoxia	2	2
Low Oxygen Saturation	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Abdominal Pain	2	2
Constipation	1	1
Respiratory Insufficiency	1	1
Swelling/ Edema	1	1
Low Blood Pressure/ Hypotension	1	1
Ulceration	1	1
Device Embedded In Tissue or Plaque	1	1
Bradycardia	1	1
Nasal Obstruction	1	1
Reaction	1	1
Awareness during Anaesthesia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien Llc	II	Apr-01-2021