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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
2020 111 111
2021 278 278
2022 248 248
2023 326 326
2024 166 166
2025 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 317 317
Output Problem 235 235
Decrease in Pressure 124 124
Pressure Problem 85 85
Electrical /Electronic Property Problem 58 58
Infusion or Flow Problem 45 45
Appropriate Term/Code Not Available 25 25
Mechanical Problem 25 25
Contamination /Decontamination Problem 22 22
Moisture or Humidity Problem 22 22
Insufficient Information 20 20
Gas Output Problem 20 20
Leak/Splash 20 20
Failure to Deliver 19 19
Adverse Event Without Identified Device or Use Problem 16 16
Power Problem 15 15
Smoking 14 14
Improper Flow or Infusion 13 13
Noise, Audible 13 13
Increase in Pressure 11 11
Material Split, Cut or Torn 11 11
Contamination 10 10
Fire 9 9
Gas/Air Leak 8 8
Sparking 5 5
Break 4 4
Crack 4 4
Unexpected Shutdown 4 4
No Flow 4 4
Complete Loss of Power 4 4
Insufficient Flow or Under Infusion 4 4
Accessory Incompatible 3 3
Failure to Shut Off 3 3
Thermal Decomposition of Device 3 3
Vibration 3 3
Flare or Flash 2 2
Melted 2 2
Electrical Shorting 1 1
Electrical Power Problem 1 1
Use of Device Problem 1 1
No Visual Prompts/Feedback 1 1
Unintended Electrical Shock 1 1
Intermittent Loss of Power 1 1
Activation Failure 1 1
Temperature Problem 1 1
Fitting Problem 1 1
Component Missing 1 1
No Pressure 1 1
Material Integrity Problem 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 946 946
No Consequences Or Impact To Patient 68 68
No Patient Involvement 44 44
No Information 38 38
Insufficient Information 30 30
Dyspnea 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Cough 9 9
Low Oxygen Saturation 9 9
Wheezing 3 3
Pneumonia 2 2
No Known Impact Or Consequence To Patient 2 2
Asthma 1 1
Bronchitis 1 1
Burn(s) 1 1
Fatigue 1 1
Unspecified Respiratory Problem 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Electric Shock 1 1

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