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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stand, infusion
Product CodeFOX
Regulation Number 880.6990
Device Class 1

MDR Year MDR Reports MDR Events
2018 17 17
2019 23 23
2020 112 112
2021 173 173
2022 15 15
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 120 120
Misconnection 71 71
Loss of or Failure to Bond 37 37
Adverse Event Without Identified Device or Use Problem 18 18
Difficult to Open or Close 16 16
Material Twisted/Bent 16 16
Disconnection 16 16
Break 11 11
Loose or Intermittent Connection 9 9
Malposition of Device 8 8
Defective Component 8 8
Contamination /Decontamination Problem 8 8
Crack 5 5
Material Separation 5 5
Fluid/Blood Leak 4 4
Product Quality Problem 4 4
Difficult to Remove 4 4
Patient-Device Incompatibility 3 3
Therapeutic or Diagnostic Output Failure 3 3
Component Missing 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Defective Device 3 3
Mechanical Problem 2 2
Material Deformation 2 2
Degraded 2 2
Inadequate Instructions for Healthcare Professional 1 1
Incorrect Measurement 1 1
Device Difficult to Setup or Prepare 1 1
Shipping Damage or Problem 1 1
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
Device Tipped Over 1 1
Connection Problem 1 1
Material Frayed 1 1
Delivered as Unsterile Product 1 1
Activation Failure 1 1
Infusion or Flow Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Physical Resistance/Sticking 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Unsealed Device Packaging 1 1
Insufficient Information 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 158 158
No Consequences Or Impact To Patient 136 136
No Known Impact Or Consequence To Patient 17 17
No Patient Involvement 10 10
Ulcer 9 9
Insufficient Information 6 6
Erythema 4 4
Foreign Body Reaction 3 3
Skin Irritation 2 2
Purulent Discharge 1 1
Itching Sensation 1 1
Blister 1 1
Skin Tears 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 1 1
Skin Inflammation/ Irritation 1 1
Foreign Body In Patient 1 1
Death 1 1
Inflammation 1 1
Swelling 1 1
Complaint, Ill-Defined 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ohmeda Medical II Mar-26-2018
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