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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stabilizer, heart
Product CodeMWS
Regulation Number 870.4500
Device Class 1

MDR Year MDR Reports MDR Events
2017 45 45
2018 52 52
2019 57 57
2020 43 43
2021 74 74
2022 98 98

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 69 69
Break 57 57
Positioning Failure 44 44
Suction Problem 19 19
Positioning Problem 15 15
Device Operates Differently Than Expected 14 14
Detachment of Device or Device Component 13 13
Loose or Intermittent Connection 13 13
Component Missing 13 13
Physical Resistance/Sticking 12 12
Suction Failure 11 11
Mechanics Altered 9 9
Packaging Problem 7 7
Defective Component 7 7
Device Slipped 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Material Too Rigid or Stiff 5 5
Device Damaged Prior to Use 5 5
Use of Device Problem 5 5
Unstable 4 4
Material Deformation 4 4
Unintended Movement 3 3
Material Too Soft/Flexible 3 3
Insufficient Information 3 3
Defective Device 3 3
Device Inoperable 3 3
Difficult To Position 3 3
Fracture 3 3
Detachment Of Device Component 3 3
Component Falling 2 2
Decrease in Suction 2 2
Device Difficult to Setup or Prepare 2 2
Material Separation 2 2
Connection Problem 2 2
Activation, Positioning or Separation Problem 2 2
Incomplete or Missing Packaging 2 2
Improper or Incorrect Procedure or Method 2 2
Illegible Information 2 2
Torn Material 2 2
No Apparent Adverse Event 1 1
Power Problem 1 1
Pressure Problem 1 1
Device Contamination With Biological Material 1 1
Device Damaged by Another Device 1 1
Device Dislodged or Dislocated 1 1
Environmental Particulates 1 1
Activation Problem 1 1
Misassembled During Installation 1 1
Noise, Audible 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Fitting Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Contamination /Decontamination Problem 1 1
Shipping Damage or Problem 1 1
Device Difficult to Program or Calibrate 1 1
Poor Quality Image 1 1
Unintended System Motion 1 1
Failure To Adhere Or Bond 1 1
Material Fragmentation 1 1
Crack 1 1
Burst Container or Vessel 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 154 154
No Known Impact Or Consequence To Patient 97 97
No Consequences Or Impact To Patient 79 79
Insufficient Information 13 13
No Information 12 12
No Patient Involvement 11 11
Hematoma 5 5
Tissue Damage 3 3
Foreign Body In Patient 2 2
Injury 2 2
Post Operative Wound Infection 1 1
Blood Loss 1 1
Patient Problem/Medical Problem 1 1
Ventricular Fibrillation 1 1
Rupture 1 1
Hemorrhage/Bleeding 1 1
Ischemia 1 1
Myocardial Infarction 1 1
Abrasion 1 1
Stroke/CVA 1 1
Death 1 1
Non specific EKG/ECG Changes 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Terumo Cardiovascular Systems Corporation II Apr-06-2021
2 Terumo Cardiovascular Systems Corporation II Feb-22-2017
3 Terumo Cardiovascular Systems Corporation II Feb-14-2017
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