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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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 316 316
Output Problem 232 232
Decrease in Pressure 124 124
Pressure Problem 85 85
Electrical /Electronic Property Problem 58 58
Infusion or Flow Problem 29 29
Mechanical Problem 25 25
Contamination /Decontamination Problem 22 22
Failure to Deliver 19 19
Leak/Splash 18 18
Insufficient Information 18 18
Appropriate Term/Code Not Available 16 16
Power Problem 15 15
Noise, Audible 13 13
Smoking 13 13
Gas Output Problem 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Improper Flow or Infusion 12 12
Increase in Pressure 11 11
Material Split, Cut or Torn 11 11
Contamination 10 10
Fire 9 9
Moisture or Humidity Problem 9 9
Gas/Air Leak 8 8
Sparking 5 5
Crack 4 4
Break 4 4
Unexpected Shutdown 4 4
No Flow 4 4
Vibration 3 3
Accessory Incompatible 3 3
Thermal Decomposition of Device 3 3
Insufficient Flow or Under Infusion 3 3
Complete Loss of Power 3 3
Failure to Shut Off 3 3
Flare or Flash 2 2
Melted 2 2
Complete Blockage 1 1
Material Puncture/Hole 1 1
Unintended Electrical Shock 1 1
Electrical Power Problem 1 1
Material Integrity Problem 1 1
Unintended Power Up 1 1
Degraded 1 1
Material Fragmentation 1 1
No Pressure 1 1
No Visual Prompts/Feedback 1 1
Component Missing 1 1
Electrical Shorting 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 917 917
No Consequences Or Impact To Patient 68 68
No Patient Involvement 44 44
No Information 38 38
Insufficient Information 21 21
Dyspnea 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Low Oxygen Saturation 8 8
Cough 6 6
Wheezing 2 2
No Known Impact Or Consequence To Patient 2 2
Pneumonia 2 2
Electric Shock 1 1
Asthma 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Burn(s) 1 1
Unspecified Respiratory Problem 1 1
Bronchitis 1 1

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