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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 278 279
2022 248 248
2023 325 327
2024 166 166
2025 110 110

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 317 318
Output Problem 239 239
Decrease in Pressure 125 125
Pressure Problem 87 87
Electrical /Electronic Property Problem 58 58
Infusion or Flow Problem 55 55
Gas Output Problem 34 34
Moisture or Humidity Problem 30 30
Insufficient Information 28 28
Appropriate Term/Code Not Available 26 26
Mechanical Problem 26 26
Contamination /Decontamination Problem 22 22
Leak/Splash 20 20
Failure to Deliver 20 20
Adverse Event Without Identified Device or Use Problem 17 17
Noise, Audible 15 15
Power Problem 15 15
Improper Flow or Infusion 15 15
Smoking 14 15
Increase in Pressure 11 12
Material Split, Cut or Torn 11 11
Contamination 10 10
Fire 10 10
Gas/Air Leak 8 8
Insufficient Flow or Under Infusion 6 6
Sparking 5 5
Unexpected Shutdown 4 4
No Flow 4 4
Complete Loss of Power 4 4
Crack 4 4
Break 4 4
Temperature Problem 3 3
Vibration 3 3
Accessory Incompatible 3 3
Failure to Shut Off 3 3
Thermal Decomposition of Device 3 3
Flare or Flash 2 2
Melted 2 2
No Device Output 1 1
Failure to Run on Battery 1 1
Fluid/Blood Leak 1 1
Intermittent Loss of Power 1 1
Overheating of Device 1 1
Connection Problem 1 1
Inaccurate Delivery 1 1
Fracture 1 1
Signal Artifact/Noise 1 1
Fitting Problem 1 1
Device Emits Odor 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 979 982
No Consequences Or Impact To Patient 68 68
No Patient Involvement 44 44
No Information 38 38
Insufficient Information 37 37
Dyspnea 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Low Oxygen Saturation 11 11
Cough 10 10
Wheezing 7 7
Unspecified Respiratory Problem 3 3
Asthma 2 2
No Known Impact Or Consequence To Patient 2 2
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

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