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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
Loose or Intermittent Connection 13 13
Component Missing 13 13
Detachment of Device or Device Component 13 13
Physical Resistance/Sticking 12 12
Suction Failure 11 11
Mechanics Altered 9 9
Packaging Problem 7 7
Device Slipped 7 7
Defective Component 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Device Damaged Prior to Use 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Use of Device Problem 5 5
Material Too Rigid or Stiff 5 5
Unstable 4 4
Material Deformation 4 4
Unintended Movement 3 3
Detachment Of Device Component 3 3
Device Inoperable 3 3
Fracture 3 3
Difficult To Position 3 3
Defective Device 3 3
Insufficient Information 3 3
Material Too Soft/Flexible 3 3
Activation, Positioning or Separation Problem 2 2
Torn Material 2 2
Device Difficult to Setup or Prepare 2 2
Connection Problem 2 2
Component Falling 2 2
Decrease in Suction 2 2
Material Separation 2 2
Incomplete or Missing Packaging 2 2
Illegible Information 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination With Biological Material 1 1
Failure To Adhere Or Bond 1 1
Poor Quality Image 1 1
Power Problem 1 1
Pressure Problem 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Burst Container or Vessel 1 1
Material Fragmentation 1 1
Device Damaged by Another Device 1 1
Environmental Particulates 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Misassembled During Installation 1 1
Unintended System Motion 1 1
Device Difficult to Program or Calibrate 1 1
Contamination /Decontamination Problem 1 1
Shipping Damage or Problem 1 1
Collapse 1 1
Crack 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1
Structural Problem 1 1
Activation Problem 1 1
Noise, Audible 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
Ventricular Fibrillation 1 1
Rupture 1 1
Non specific EKG/ECG Changes 1 1
Ischemia 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Stroke/CVA 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Myocardial Infarction 1 1
Abrasion 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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