TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	29	29
Crack	24	24
Break	23	23
Gas/Air Leak	17	17
Connection Problem	15	15
Melted	15	15
Disconnection	15	15
Material Separation	14	14
Leak/Splash	11	11
Air Leak	8	8
Loose or Intermittent Connection	7	7
Fitting Problem	7	7
Device Contamination with Chemical or Other Material	6	6
Detachment Of Device Component	5	5
Defective Device	5	5
Detachment of Device or Device Component	5	5
Fracture	4	4
Hole In Material	4	4
Use of Device Problem	4	4
Material Fragmentation	4	4
Mechanical Problem	3	3
Component Incompatible	3	3
Failure to Disconnect	3	3
Misconnection	2	2
Device Handling Problem	2	2
Material Rupture	2	2
Packaging Problem	2	2
Degraded	2	2
Incomplete or Inadequate Connection	2	2
Defective Component	2	2
Material Integrity Problem	2	2
Intermittent Loss of Power	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Issue	1	1
Improper Chemical Reaction	1	1
Incorrect Measurement	1	1
Output Problem	1	1
Moisture Damage	1	1
Stretched	1	1
Failure to Transmit Record	1	1
Material Puncture/Hole	1	1
Separation Failure	1	1
Material Disintegration	1	1
Component Missing	1	1
Occlusion Within Device	1	1
Device Damaged Prior to Use	1	1
Material Twisted/Bent	1	1
Obstruction of Flow	1	1
Out-Of-Box Failure	1	1
Mechanics Altered	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	77	77
No Consequences Or Impact To Patient	57	57
No Known Impact Or Consequence To Patient	34	34
No Patient Involvement	11	11
Insufficient Information	7	7
Low Oxygen Saturation	7	7
Hypoventilation	5	5
Hypoxia	4	4
Death	2	2
Foreign Body In Patient	2	2
Dyspnea	2	2
Unspecified Respiratory Problem	2	2
Extubate	2	2
Low Blood Pressure/ Hypotension	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Nausea	1	1
Brain Injury	1	1
Dizziness	1	1
No Information	1	1
Aspiration/Inhalation	1	1
Asthma	1	1
Weakness	1	1
Vomiting	1	1
Tachycardia	1	1
Anxiety	1	1
Unspecified Tissue Injury	1	1
Hyperventilation	1	1
Headache	1	1
Cancer	1	1
Unintended Extubation	1	1
Ambulation Difficulties	1	1