TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	24	24
Insufficient Information	22	22
Use of Device Problem	12	12
Suction Failure	11	11
Mechanical Problem	6	6
Defective Component	6	6
Suction Problem	6	6
Therapeutic or Diagnostic Output Failure	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Decrease in Suction	4	7
Detachment of Device or Device Component	4	4
Pressure Problem	3	3
Product Quality Problem	3	3
Defective Device	2	2
Material Separation	2	2
Leak/Splash	1	1
Device Slipped	1	1
Activation, Positioning or Separation Problem	1	1
Material Split, Cut or Torn	1	1
Output Problem	1	1
Crack	1	1
Pumping Problem	1	1
Expiration Date Error	1	2
Material Integrity Problem	1	1
Component Missing	1	1
Material Rupture	1	1
Appropriate Term/Code Not Available	1	1
Failure to Deflate	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	34	35
Insufficient Information	23	24
Cephalohematoma	9	9
Laceration(s)	9	10
Hematoma	8	8
No Known Impact Or Consequence To Patient	6	6
Hemorrhage/Bleeding	5	5
No Code Available	4	4
Fetal Distress	3	3
Skull Fracture	3	3
Intracranial Hemorrhage	3	3
No Consequences Or Impact To Patient	3	3
Bruise/Contusion	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Bone Fracture(s)	2	2
Abrasion	2	2
Discomfort	2	2
Pain	2	2
Encephalopathy	1	1
Perinatal Brain Injury	1	1
Blister	1	1
Easy Bruising	1	1
Vaginal Mucosa Damage	1	1
Foreign Body In Patient	1	1
No Patient Involvement	1	1
Hemorrhage, Subgaleal	1	1
Bradycardia	1	1
Swelling/ Edema	1	1
Hypoxia	1	1
Hemorrhage, Subarachnoid	1	1
Deformity/ Disfigurement	1	1

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