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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stand, infusion
Regulation Description Infusion stand.
Product CodeFOX
Regulation Number 880.6990
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 8 8
2018 17 17
2019 23 23
2020 112 112
2021 168 168

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 104 104
Misconnection 70 70
Loss of or Failure to Bond 37 37
Adverse Event Without Identified Device or Use Problem 18 18
Material Twisted/Bent 16 16
Disconnection 16 16
Difficult to Open or Close 16 16
Break 10 10
Loose or Intermittent Connection 9 9
Malposition of Device 8 8
Contamination /Decontamination Problem 8 8
Defective Component 8 8
Material Separation 5 5
Crack 5 5
Fluid Leak 4 4
Product Quality Problem 4 4
Difficult to Remove 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Component Missing 3 3
Patient-Device Incompatibility 3 3
Mechanical Problem 3 3
Detachment Of Device Component 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Deformation 2 2
Component Falling 2 2
Degraded 2 2
Defective Device 2 2
Device Tipped Over 1 1
Shipping Damage or Problem 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Electromagnetic Compatibility Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Failure to Charge 1 1
Failure To Run On AC/DC 1 1
Unintended Arm Motion 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Material Frayed 1 1
Inadequate Instructions for Healthcare Professional 1 1
Electromagnetic Interference 1 1
Material Integrity Problem 1 1
Device Operates Differently Than Expected 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 140 140
No Clinical Signs, Symptoms or Conditions 138 138
No Known Impact Or Consequence To Patient 20 20
No Patient Involvement 10 10
Ulcer 9 9
Insufficient Information 6 6
Erythema 3 3
Foreign Body Reaction 3 3
Skin Irritation 2 2
Swelling 1 1
Tingling 1 1
Death 1 1
Purulent Discharge 1 1
Inflammation 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Reaction 1 1
Skin Tears 1 1
Electric Shock 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
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