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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
2017 8 8
2018 17 17
2019 23 23
2020 112 112
2021 173 173
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 110 110
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
Defective Component 8 8
Malposition of Device 8 8
Contamination /Decontamination Problem 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
Detachment Of Device Component 3 3
Mechanical Problem 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 2 2
Incorrect Measurement 1 1
Shipping Damage or Problem 1 1
Improper or Incorrect Procedure or Method 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
Material Frayed 1 1
Inadequate Instructions for Healthcare Professional 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Device Difficult to Setup or Prepare 1 1
Material Integrity Problem 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Positioning Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 146 146
No Consequences Or Impact To Patient 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 Firefly Medical, Inc. II Sep-07-2017
2 Ohmeda Medical II Mar-26-2018
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