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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
2019 114 114
2020 111 111
2021 278 278
2022 248 248
2023 326 326
2024 112 112

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 346 346
Output Problem 251 251
Decrease in Pressure 130 130
Pressure Problem 88 88
Electrical /Electronic Property Problem 64 64
Mechanical Problem 25 25
Infusion or Flow Problem 24 24
Contamination /Decontamination Problem 22 22
Noise, Audible 19 19
Failure to Deliver 19 19
Leak/Splash 17 17
Power Problem 16 16
Appropriate Term/Code Not Available 15 15
Insufficient Information 14 14
Increase in Pressure 12 12
Unexpected Shutdown 11 11
Material Split, Cut or Torn 11 11
Smoking 11 11
Improper Flow or Infusion 11 11
Moisture or Humidity Problem 9 9
Gas Output Problem 9 9
Contamination 8 8
Fire 8 8
Gas/Air Leak 7 7
No Flow 5 5
Sparking 4 4
Thermal Decomposition of Device 4 4
Crack 4 4
Degraded 4 4
Accessory Incompatible 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Vibration 3 3
Failure to Shut Off 3 3
Break 3 3
Intermittent Loss of Power 2 2
Complete Loss of Power 2 2
Energy Output Problem 2 2
Inaccurate Delivery 2 2
Flare or Flash 2 2
Melted 2 2
Complete Blockage 1 1
Device Alarm System 1 1
No Pressure 1 1
Signal Artifact/Noise 1 1
Material Fragmentation 1 1
Circuit Failure 1 1
Physical Resistance/Sticking 1 1
Fluid/Blood Leak 1 1
Unintended Electrical Shock 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 882 882
No Consequences Or Impact To Patient 139 139
No Patient Involvement 84 84
No Information 39 39
Insufficient Information 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Low Oxygen Saturation 8 8
Dyspnea 5 5
No Known Impact Or Consequence To Patient 4 4
Cough 3 3
Wheezing 2 2
Pneumonia 2 2
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Underdose 1 1
Burn(s) 1 1
Asthma 1 1
Electric Shock 1 1
Unspecified Respiratory Problem 1 1

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