• 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 circulator, breathing-circuit
Product CodeCAG
Regulation Number 868.5250
Device Class 2

MDR Year MDR Reports MDR Events
2014 95 95
2015 41 41
2016 2 2
2017 2 2
2018 2 2
2019 3 3
2020 4 4
2021 13 13
2022 9 9
2023 14 14
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 39 39
Melted 28 28
Break 18 18
Crack 15 15
Material Separation 13 13
Disconnection 11 11
Hole In Material 11 11
Split 11 11
Gas/Air Leak 11 11
Misassembled 9 9
Infusion or Flow Problem 7 7
Fitting Problem 5 5
Connection Problem 5 5
Device Inoperable 4 4
Material Puncture/Hole 4 4
Detachment Of Device Component 3 3
Loss of or Failure to Bond 3 3
Defective Component 3 3
Failure to Deliver 3 3
Occlusion Within Device 3 3
Detachment of Device or Device Component 3 3
Cut In Material 2 2
Temperature Problem 2 2
Mechanical Problem 2 2
Device Damaged Prior to Use 2 2
Disassembly 2 2
Human-Device Interface Problem 2 2
Device Dislodged or Dislocated 2 2
Thermal Decomposition of Device 2 2
Device Contamination with Chemical or Other Material 2 2
Device Displays Incorrect Message 1 1
Suction Problem 1 1
Device Operates Differently Than Expected 1 1
Ambient Noise Problem 1 1
Material Rupture 1 1
Moisture or Humidity Problem 1 1
Failure to Align 1 1
Unintended Ejection 1 1
Material Fragmentation 1 1
Key or Button Unresponsive/not Working 1 1
Alarm Not Visible 1 1
No Fail-Safe Mechanism 1 1
Material Integrity Problem 1 1
Device Alarm System 1 1
Torn Material 1 1
Delivery System Failure 1 1
Communication or Transmission Problem 1 1
Output Problem 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 71 71
No Patient Involvement 63 63
No Clinical Signs, Symptoms or Conditions 38 38
No Known Impact Or Consequence To Patient 19 19
Insufficient Information 8 8
Low Oxygen Saturation 3 3
No Code Available 2 2
No Information 2 2
Death 1 1
Anxiety 1 1

-
-