Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
Material Twisted/Bent 16 16
Disconnection 16 16
Difficult to Open or Close 16 16
Break 11 11
Loose or Intermittent Connection 9 9
Contamination /Decontamination Problem 8 8
Defective Component 8 8
Malposition of Device 8 8
Material Separation 5 5
Crack 5 5
Fluid/Blood Leak 4 4
Product Quality Problem 4 4
Difficult to Remove 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Patient-Device Incompatibility 3 3
Component Missing 3 3
Defective Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
Mechanical Problem 2 2
Material Deformation 2 2
Degraded 2 2
Material Frayed 1 1
Inadequate Instructions for Healthcare Professional 1 1
Incorrect Measurement 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
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Tipped Over 1 1
Shipping Damage or Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Positioning Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 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 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
Swelling 1 1
Death 1 1
Purulent Discharge 1 1
Inflammation 1 1
Itching Sensation 1 1
Complaint, Ill-Defined 1 1
Reaction 1 1
Skin Tears 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Blister 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 Ohmeda Medical II Mar-26-2018
-
-