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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
2014 2 2
2015 3 3
2016 2 2
2017 8 8
2018 17 17
2019 23 23
2020 112 112
2021 173 173
2022 12 12
2023 3 3
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 119 119
Misconnection 72 72
Loss of or Failure to Bond 37 37
Adverse Event Without Identified Device or Use Problem 19 19
Disconnection 16 16
Difficult to Open or Close 16 16
Material Twisted/Bent 16 16
Break 13 13
Loose or Intermittent Connection 9 9
Defective Component 9 9
Contamination /Decontamination Problem 8 8
Malposition of Device 8 8
Mechanical Problem 5 5
Detachment Of Device Component 5 5
Crack 5 5
Material Separation 5 5
Difficult to Remove 4 4
Fluid/Blood Leak 4 4
Product Quality Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Patient-Device Incompatibility 3 3
Component Falling 3 3
Component Missing 3 3
Therapeutic or Diagnostic Output Failure 3 3
Defective Device 3 3
Device Tipped Over 3 3
Degraded 2 2
Material Deformation 2 2
Shipping Damage or Problem 1 1
Device Difficult to Setup or Prepare 1 1
Structural Problem 1 1
Infusion or Flow Problem 1 1
Unsealed Device Packaging 1 1
Delivered as Unsterile Product 1 1
Electromagnetic Compatibility Problem 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Activation Failure 1 1
Smoking 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination with Chemical or Other Material 1 1
Failure To Run On AC/DC 1 1
Incorrect Measurement 1 1
Unintended Arm Motion 1 1
Improper or Incorrect Procedure or Method 1 1
Physical Resistance/Sticking 1 1
Fire 1 1
Material Split, Cut or Torn 1 1
Unintended Collision 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 163 163
No Consequences Or Impact To Patient 140 140
No Known Impact Or Consequence To Patient 20 20
No Patient Involvement 10 10
Ulcer 9 9
Insufficient Information 6 6
Erythema 4 4
Foreign Body Reaction 3 3
Skin Irritation 2 2
No Information 2 2
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Infection 1 1
Tingling 1 1
Electric Shock 1 1
Complaint, Ill-Defined 1 1
Death 1 1
Skin Inflammation/ Irritation 1 1
Head Injury 1 1
Inflammation 1 1
Abrasion 1 1
No Patient involvement 1 1
Purulent Discharge 1 1
Itching Sensation 1 1
Blister 1 1
Injury 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Laceration(s) 1 1
Physical Entrapment 1 1
Reaction 1 1
Contact Dermatitis 1 1
Skin Tears 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EKOS Corporation II Sep-27-2016
2 Firefly Medical, Inc. II Sep-07-2017
3 Firefly Medical, Inc. II Dec-15-2016
4 Ohmeda Medical II Mar-26-2018
5 Stryker Medical Division of Stryker Corporation II Nov-30-2015
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