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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 325 325
2024 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 343 343
Output Problem 244 244
Decrease in Pressure 130 130
Pressure Problem 87 87
Electrical /Electronic Property Problem 64 64
Mechanical Problem 25 25
Contamination /Decontamination Problem 22 22
Noise, Audible 19 19
Infusion or Flow Problem 17 17
Failure to Deliver 17 17
Power Problem 16 16
Leak/Splash 14 14
Increase in Pressure 11 11
Material Split, Cut or Torn 11 11
Unexpected Shutdown 11 11
Appropriate Term/Code Not Available 11 11
Improper Flow or Infusion 10 10
Moisture or Humidity Problem 9 9
Smoking 9 9
Contamination 8 8
Insufficient Information 8 8
Gas/Air Leak 7 7
Sparking 4 4
No Flow 4 4
Degraded 4 4
Thermal Decomposition of Device 4 4
Fire 4 4
Accessory Incompatible 3 3
Crack 3 3
Vibration 3 3
Break 3 3
Failure to Shut Off 3 3
Inaccurate Delivery 2 2
Melted 2 2
Energy Output Problem 2 2
Intermittent Loss of Power 2 2
Unintended Electrical Shock 1 1
Intermittent Energy Output 1 1
Suction Failure 1 1
No Pressure 1 1
Material Integrity Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Physical Resistance/Sticking 1 1
Complete Loss of Power 1 1
Overheating of Device 1 1
Loss of Power 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Material Fragmentation 1 1
Gas Output Problem 1 1
Unintended Power Up 1 1
Device Alarm System 1 1
Signal Artifact/Noise 1 1
Circuit Failure 1 1
Complete Blockage 1 1
Device Displays Incorrect Message 1 1
Flare or Flash 1 1
Device Contamination with Chemical or Other Material 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 847 847
No Consequences Or Impact To Patient 139 139
No Patient Involvement 84 84
No Information 39 39
Low Oxygen Saturation 8 8
Insufficient Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Known Impact Or Consequence To Patient 4 4
Cough 2 2
Wheezing 1 1
Unspecified Respiratory Problem 1 1
Underdose 1 1
Electric Shock 1 1
Pneumonia 1 1

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