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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device warmer, thermal, infusion fluid
Product CodeLGZ
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
BARKEY GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LIFE WARMER, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAC MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
QUALITY IN FLOW LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMISSON-CARTLEDGE BIOMEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 95 95
2019 340 340
2020 1221 1221
2021 886 886
2022 1548 1548
2023 373 373

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 915 915
Leak/Splash 478 478
Device Alarm System 395 395
Temperature Problem 339 339
Display or Visual Feedback Problem 227 227
Crack 171 171
Power Problem 160 160
Break 158 158
Mechanical Problem 158 158
No Audible Alarm 123 123
Defective Alarm 111 111
Overheating of Device 101 101
Insufficient Heating 100 100
Electrical /Electronic Property Problem 91 91
Excessive Heating 82 82
Failure to Power Up 80 80
False Alarm 78 78
Defective Component 76 76
No Display/Image 73 73
Noise, Audible 69 69
Pumping Problem 59 59
Infusion or Flow Problem 51 51
Failure to Calibrate 45 45
Connection Problem 44 44
Fracture 43 43
Pressure Problem 43 43
Defective Device 40 40
Display Difficult to Read 39 39
Failure to Pump 38 38
Output Problem 36 36
Improper Flow or Infusion 33 33
Device Sensing Problem 32 32
Device Damaged Prior to Use 32 32
Calibration Problem 32 32
Insufficient Flow or Under Infusion 30 30
Patient Device Interaction Problem 30 30
Audible Prompt/Feedback Problem 28 28
Smoking 28 28
Material Separation 27 27
Component Missing 27 27
Circuit Failure 25 25
Device Displays Incorrect Message 21 21
Erratic or Intermittent Display 20 20
Appropriate Term/Code Not Available 16 16
No Flow 15 15
Increase in Pressure 15 15
Insufficient Information 14 14
No Visual Prompts/Feedback 13 13
Naturally Worn 13 13
Material Twisted/Bent 13 13
Device Emits Odor 13 13
Fire 13 13
Detachment of Device or Device Component 13 13
Failure to Deliver 12 12
Image Display Error/Artifact 12 12
Fitting Problem 11 11
Failure to Sense 11 11
Complete Loss of Power 11 11
Intermittent Loss of Power 11 11
No Tactile Prompts/Feedback 10 10
Failure of Device to Self-Test 10 10
Obstruction of Flow 10 10
Contamination /Decontamination Problem 10 10
Material Fragmentation 10 10
Contamination 10 10
Alarm Not Visible 10 10
Electrical Power Problem 9 9
Device Difficult to Setup or Prepare 9 9
Use of Device Problem 9 9
No Apparent Adverse Event 9 9
Device Fell 9 9
Key or Button Unresponsive/not Working 8 8
Material Integrity Problem 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Protective Measures Problem 8 8
No Audible Prompt/Feedback 8 8
Unable to Obtain Readings 8 8
Failure to Infuse 8 8
Grounding Malfunction 8 8
Loose or Intermittent Connection 8 8
Particulates 7 7
Failure to Conduct 7 7
Thermal Decomposition of Device 7 7
Disconnection 7 7
Corroded 7 7
Sparking 7 7
Electrical Shorting 7 7
Deformation Due to Compressive Stress 7 7
Material Deformation 7 7
Material Split, Cut or Torn 7 7
Air/Gas in Device 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Flare or Flash 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Degraded 6 6
Poor Quality Image 6 6
Inaccurate Flow Rate 6 6
Material Discolored 5 5
Loss of Power 5 5
Electrical Overstress 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2167 2167
No Information 756 756
Insufficient Information 653 653
No Patient Involvement 514 514
No Consequences Or Impact To Patient 312 312
No Known Impact Or Consequence To Patient 287 287
Death 6 6
No Code Available 6 6
Hypovolemic Shock 4 4
Patient Problem/Medical Problem 4 4
Urethral Stenosis/Stricture 3 3
Injury 2 2
Cardiac Arrest 2 2
Aneurysm 2 2
Hypothermia 2 2
Bruise/Contusion 2 2
Hemorrhage/Bleeding 2 2
Electric Shock 2 2
Exsanguination 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Ruptured Aneurysm 2 2
Burn(s) 2 2
Thrombosis/Thrombus 1 1
Shock 1 1
Not Applicable 1 1
Adhesion(s) 1 1
Infiltration into Tissue 1 1
Superficial (First Degree) Burn 1 1
Low Blood Pressure/ Hypotension 1 1
Low Oxygen Saturation 1 1
Missing Value Reason 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Eight Medical International BV I Jul-23-2021
2 RanD S.r.l. II Jul-09-2021
3 Smisson-Cartledge Biomedical, LLC I Mar-26-2021
4 Smiths Medical ASD Inc. I Sep-03-2021
5 Vyaire Medical I Jun-26-2019
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