TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	39	39
Insufficient Information	27	27
Device Operates Differently Than Expected	19	19
Use of Device Problem	15	15
Suction Problem	15	15
Suction Failure	12	12
Detachment of Device or Device Component	11	11
Adverse Event Without Identified Device or Use Problem	9	9
Appropriate Term/Code Not Available	8	8
Decrease in Suction	8	8
Detachment Of Device Component	7	7
Material Separation	7	7
Defective Component	6	6
Therapeutic or Diagnostic Output Failure	6	6
Mechanical Problem	5	5
Pressure Problem	4	4
Defective Device	4	4
Product Quality Problem	3	3
Difficult to Remove	3	3
Material Rupture	3	3
Failure to Pump	2	2
Sticking	2	2
Crack	2	2
Disconnection	2	2
Entrapment of Device	2	2
Material Fragmentation	2	2
Device Inoperable	2	2
Device Dislodged or Dislocated	2	2
Dent in Material	2	2
No Pressure	2	2
Material Split, Cut or Torn	2	2
Pumping Problem	2	2
Activation Problem	1	1
Failure to Deflate	1	1
Output Problem	1	1
Protective Measures Problem	1	1
Expiration Date Error	1	1
Failure to Disconnect	1	1
Connection Problem	1	1
Activation, Positioning or Separation Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Gas/Air Leak	1	1
Human-Device Interface Problem	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Mechanical Jam	1	1
Failure To Adhere Or Bond	1	1
Improper or Incorrect Procedure or Method	1	1
Component Missing	1	1
Fitting Problem	1	1
Leak/Splash	1	1
Unintended Ejection	1	1
Deflation Problem	1	1
Increase in Suction	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	46	46
Insufficient Information	19	19
No Clinical Signs, Symptoms or Conditions	19	19
No Consequences Or Impact To Patient	15	15
Cephalohematoma	15	15
Hemorrhage, Subgaleal	12	12
Laceration(s)	11	11
Hematoma	11	11
No Information	9	9
Death	7	7
Hemorrhage/Bleeding	6	6
Skull Fracture	6	6
No Code Available	6	6
Bone Fracture(s)	4	4
Abrasion	4	4
Perinatal Brain Injury	3	3
Fetal Distress	3	3
Intracranial Hemorrhage	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Injury	2	2
Vaginal Mucosa Damage	2	2
Bradycardia	2	2
Bruise/Contusion	2	2
Suffocation	2	2
Hemorrhage, Subdural	2	2
No Patient Involvement	2	2
Rupture	2	2
Hypoxia in Utero	1	1
Brain Injury	1	1
Shock, Traumatic	1	1
Foreign Body In Patient	1	1
Patient Problem/Medical Problem	1	1
Hypoxia	1	1
Occlusion	1	1
Pain	1	1
Swelling	1	1
Tachycardia	1	1
Tissue Damage	1	1
Bacterial Infection	1	1
Exposure to Body Fluids	1	1
Edema	1	1
Encephalopathy	1	1
Extreme Exhaustion	1	1
Hemorrhage, Subarachnoid	1	1
Head Injury	1	1
Deformity/ Disfigurement	1	1
Pallor	1	1
Blister	1	1
Easy Bruising	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Clinical Innovations, LLC	II	May-21-2020