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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device warmer, blood, non-electromagnetic radiation
Product CodeBSB
Regulation Number 864.9205
Device Class 2


Premarket Reviews
ManufacturerDecision
BELMONT INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 10 10
2015 11 11
2016 66 66
2017 29 29
2018 36 36
2019 147 147
2020 216 216
2021 341 341
2022 447 447
2023 292 292
2024 128 128

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 401 401
Device Alarm System 190 190
Temperature Problem 112 112
Pressure Problem 96 96
Insufficient Flow or Under Infusion 71 71
Insufficient Information 66 66
Leak/Splash 64 64
Insufficient Heating 58 58
Overheating of Device 49 49
Appropriate Term/Code Not Available 46 46
Break 38 38
False Alarm 35 35
Device Markings/Labelling Problem 34 34
Defective Component 33 33
Defective Alarm 32 32
Failure to Power Up 32 32
Infusion or Flow Problem 28 28
Noise, Audible 28 28
Power Problem 27 27
Mechanical Problem 26 26
Crack 23 23
Component Missing 23 23
Failure to Calibrate 22 22
Device Sensing Problem 22 22
Failure to Pump 22 22
Decrease in Pressure 20 20
Inflation Problem 19 19
Excessive Heating 18 18
Fracture 16 16
Electrical /Electronic Property Problem 16 16
Calibration Problem 16 16
Connection Problem 15 15
No Flow 14 14
No Audible Alarm 14 14
No Display/Image 13 13
Defective Device 13 13
Device Emits Odor 12 12
Smoking 11 11
Pumping Problem 11 11
Improper Flow or Infusion 11 11
Output Problem 10 10
Display or Visual Feedback Problem 10 10
Air/Gas in Device 10 10
Output below Specifications 9 9
Failure to Deliver 9 9
Inaccurate Delivery 8 8
No Pressure 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Inaccurate Flow Rate 7 7
Detachment of Device or Device Component 7 7
Unexpected Shutdown 7 7
Missing Value Reason 7 7
Intermittent Loss of Power 6 6
Key or Button Unresponsive/not Working 6 6
Device Displays Incorrect Message 6 6
Electrical Power Problem 6 6
Loose or Intermittent Connection 6 6
Failure to Sense 6 6
Complete Blockage 6 6
Display Difficult to Read 6 6
Failure to Cycle 5 5
Material Fragmentation 5 5
Device Damaged Prior to Use 5 5
Increased Sensitivity 5 5
Gas/Air Leak 5 5
Failure to Shut Off 5 5
Audible Prompt/Feedback Problem 5 5
Device Difficult to Maintain 4 4
Component Misassembled 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Disconnection 4 4
Circuit Failure 4 4
Material Separation 4 4
Fitting Problem 4 4
Material Rupture 4 4
Improper or Incorrect Procedure or Method 4 4
Moisture Damage 3 3
Pumping Stopped 3 3
Thermal Decomposition of Device 3 3
Restricted Flow rate 3 3
Hole In Material 3 3
Mechanical Jam 3 3
Failure of Device to Self-Test 3 3
Incomplete or Missing Packaging 3 3
Failure to Infuse 3 3
Sparking 3 3
Complete Loss of Power 3 3
No Apparent Adverse Event 2 2
Misassembled During Installation 2 2
Misassembly During Maintenance/Repair 2 2
Incomplete or Inadequate Connection 2 2
Priming Problem 2 2
Contamination /Decontamination Problem 2 2
Component or Accessory Incompatibility 2 2
Electrical Shorting 2 2
Environmental Particulates 2 2
Device-Device Incompatibility 2 2
Difficult to Open or Close 2 2
Device Contamination with Body Fluid 2 2
Obstruction of Flow 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 987 987
Insufficient Information 282 282
Not Applicable 152 152
No Information 131 131
No Patient Involvement 107 107
No Consequences Or Impact To Patient 84 84
No Known Impact Or Consequence To Patient 74 74
Death 10 10
Missing Value Reason 5 5
No Code Available 2 2
Blood Loss 2 2
Air Embolism 2 2
Burn(s) 2 2
Cardiac Arrest 2 2
Complaint, Ill-Defined 1 1
Surgical procedure, delayed 1 1
Superficial (First Degree) Burn 1 1
Non specific EKG/ECG Changes 1 1
Hemorrhage/Bleeding 1 1
Hypovolemic Shock 1 1
Unspecified Infection 1 1
Paralysis 1 1
Pneumothorax 1 1
Septic Shock 1 1
Swelling 1 1
Unspecified Heart Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Estill Medical Technologies, Inc II Oct-21-2014
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