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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
ACACIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARKEY GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BELMONT INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 2
BELMONT INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIEGLER GMBH
  SUBSTANTIALLY EQUIVALENT 1
CRECHE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
EMIT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENTHERMICS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEI, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPERIAL SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFE WARMER, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAC MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL RESCUE EQUIPMENT HOLDING AS
  SUBSTANTIALLY EQUIVALENT 1
NATUS NICOLET IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1
QUALITY IN FLOW LTD.
  SUBSTANTIALLY EQUIVALENT 5
RAND S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SMISSON-CARTLEDGE BIOMEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
THE SURGICAL COMPANY INTERNATIONAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
THERMAL THERAPEUTIC SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 23 23
2015 34 34
2016 15 15
2017 58 58
2018 94 94
2019 340 340
2020 1221 1221
2021 884 884
2022 1548 1548
2023 1032 1032
2024 275 275

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1198 1198
Leak/Splash 539 539
Device Alarm System 478 478
Temperature Problem 382 382
Display or Visual Feedback Problem 267 267
Crack 224 224
Break 200 200
Power Problem 176 176
Mechanical Problem 160 160
Defective Alarm 153 153
No Audible Alarm 152 152
Overheating of Device 134 134
Insufficient Heating 131 131
Electrical /Electronic Property Problem 112 112
Failure to Power Up 104 104
Defective Component 99 99
False Alarm 99 99
Noise, Audible 95 95
Fracture 91 91
Excessive Heating 87 87
No Display/Image 84 84
Failure to Pump 73 73
Pumping Problem 70 70
Connection Problem 65 65
Infusion or Flow Problem 58 58
Failure to Calibrate 54 54
Pressure Problem 48 48
Device Sensing Problem 46 46
Material Separation 44 44
Display Difficult to Read 43 43
Defective Device 40 40
Output Problem 39 39
Improper Flow or Infusion 37 37
Component Missing 37 37
Smoking 37 37
Audible Prompt/Feedback Problem 36 36
Detachment of Device or Device Component 35 35
Calibration Problem 35 35
Device Damaged Prior to Use 34 34
Circuit Failure 31 31
Insufficient Flow or Under Infusion 30 30
Patient Device Interaction Problem 30 30
Alarm Not Visible 29 29
Device Displays Incorrect Message 28 28
Insufficient Information 27 27
Key or Button Unresponsive/not Working 27 27
Incorrect, Inadequate or Imprecise Result or Readings 24 24
Failure to Sense 23 23
Failure to Deliver 23 23
Erratic or Intermittent Display 22 22
No Flow 21 21
Corroded 20 20
Disconnection 18 18
Image Display Error/Artifact 16 16
Fire 16 16
Increase in Pressure 16 16
Device Emits Odor 16 16
Appropriate Term/Code Not Available 16 16
Air/Gas in Device 15 15
Fitting Problem 15 15
Use of Device Problem 14 14
No Visual Prompts/Feedback 14 14
Material Twisted/Bent 14 14
Device Operates Differently Than Expected 14 14
Contamination /Decontamination Problem 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Naturally Worn 13 13
Intermittent Loss of Power 13 13
Contamination 13 13
Material Fragmentation 12 12
Complete Loss of Power 12 12
Obstruction of Flow 12 12
Failure of Device to Self-Test 11 11
Grounding Malfunction 11 11
No Audible Prompt/Feedback 11 11
Sparking 11 11
Loose or Intermittent Connection 10 10
Thermal Decomposition of Device 10 10
No Apparent Adverse Event 10 10
No Tactile Prompts/Feedback 10 10
Device Difficult to Maintain 9 9
Device Fell 9 9
Material Integrity Problem 9 9
Electrical Power Problem 9 9
Poor Quality Image 9 9
Device Difficult to Setup or Prepare 9 9
Unable to Obtain Readings 8 8
Failure to Infuse 8 8
Electrical Shorting 8 8
Electrical Overstress 8 8
Device Contamination with Chemical or Other Material 8 8
Deformation Due to Compressive Stress 8 8
Material Deformation 8 8
Protective Measures Problem 8 8
Material Split, Cut or Torn 7 7
Flare or Flash 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Low Readings 7 7
Loss of Power 7 7
Particulates 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2748 2748
Insufficient Information 1183 1183
No Information 765 765
No Patient Involvement 519 519
No Known Impact Or Consequence To Patient 367 367
No Consequences Or Impact To Patient 333 333
Death 10 10
No Code Available 7 7
Patient Problem/Medical Problem 4 4
Hypothermia 4 4
Hypovolemic Shock 4 4
Bruise/Contusion 3 3
Low Blood Pressure/ Hypotension 3 3
Electric Shock 3 3
Urethral Stenosis/Stricture 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Not Applicable 2 2
Blood Loss 2 2
Injury 2 2
Ruptured Aneurysm 2 2
Burn(s) 2 2
Cardiac Arrest 2 2
Aneurysm 2 2
Exsanguination 2 2
Hemorrhage/Bleeding 2 2
Ischemia 2 2
Shock 1 1
Swelling 1 1
Tachycardia 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Hypoglycemia 1 1
Adhesion(s) 1 1
Thrombosis/Thrombus 1 1
Missing Value Reason 1 1
Partial thickness (Second Degree) Burn 1 1
Respiratory Failure 1 1
Rupture 1 1
Complaint, Ill-Defined 1 1
Superficial (First Degree) Burn 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Eight Medical International BV I Jul-23-2021
2 Enginivity LLC II Sep-04-2009
3 Natus Manufacturing Limited II Jan-06-2017
4 RanD S.r.l. II Jul-09-2021
5 Smisson-Cartledge Biomedical, LLC I Mar-26-2021
6 Smiths Medical ASD Inc. I Sep-03-2021
7 Smiths Medical ASD, Inc. III Feb-07-2017
8 Smiths Medical ASD, Inc. II Apr-09-2014
9 Smiths Medical ASD, Inc. II Jul-09-2012
10 Smiths Medical ASD, Inc. II Jan-11-2012
11 Steris Corporation II Jan-06-2016
12 Vital Signs Devices, a GE Healthcare Company II Jul-09-2012
13 Vital Signs Devices, a GE Healthcare Company II Aug-19-2011
14 Vital Signs Inc II Sep-03-2010
15 Vyaire Medical I Jun-26-2019
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