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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device compressor, air, portable
Regulation Description Portable air compressor.
Product CodeBTI
Regulation Number 868.6250
Device Class 2

MDR Year MDR Reports MDR Events
2021 278 279
2022 248 248
2023 325 327
2024 166 166
2025 120 120
2026 182 182

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 292 293
Output Problem 241 241
Decrease in Pressure 126 126
Infusion or Flow Problem 114 114
Pressure Problem 54 54
Gas Output Problem 52 52
Electrical /Electronic Property Problem 44 44
Insufficient Information 41 41
Failure to Deliver 40 40
Moisture or Humidity Problem 33 33
Mechanical Problem 31 31
Appropriate Term/Code Not Available 27 27
Improper Flow or Infusion 23 23
Noise, Audible 21 21
Contamination /Decontamination Problem 21 21
Leak/Splash 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Power Problem 17 17
Smoking 14 15
Material Split, Cut or Torn 11 11
Increase in Pressure 11 12
Insufficient Flow or Under Infusion 10 10
Contamination 10 10
Fire 8 8
Gas/Air Leak 8 8
Break 6 6
Crack 6 6
Excessive Heating 6 6
Sparking 5 5
No Flow 4 4
Complete Loss of Power 4 4
Lack of Effect 4 4
Temperature Problem 3 3
No Device Output 3 3
Connection Problem 3 3
Device Emits Odor 3 3
Thermal Decomposition of Device 3 3
Component Missing 3 3
No Pressure 3 3
Vibration 3 3
Accessory Incompatible 3 3
Failure to Shut Off 3 3
Flare or Flash 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Integrity Problem 2 2
No Apparent Adverse Event 2 2
Restricted Flow rate 2 2
Melted 2 2
Unexpected Shutdown 2 2
Fluid/Blood Leak 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1125 1128
Insufficient Information 67 67
Dyspnea 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
No Consequences Or Impact To Patient 18 18
No Patient Involvement 13 13
Cough 12 12
Low Oxygen Saturation 11 11
No Information 10 10
Wheezing 7 7
Unspecified Respiratory Problem 5 5
Asthma 4 4
Pneumonia 2 2
Bronchitis 2 2
Unspecified Infection 1 1
Electric Shock 1 1
Fatigue 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Burn(s) 1 1
Hypoxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Datex-Ohmeda, Inc. I Jan-30-2024
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