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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 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 345 345
Output Problem 245 245
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 18 18
Failure to Deliver 18 18
Power Problem 16 16
Leak/Splash 14 14
Appropriate Term/Code Not Available 13 13
Unexpected Shutdown 11 11
Material Split, Cut or Torn 11 11
Improper Flow or Infusion 11 11
Increase in Pressure 11 11
Smoking 9 9
Moisture or Humidity Problem 9 9
Insufficient Information 8 8
Contamination 8 8
Gas/Air Leak 7 7
Fire 5 5
Degraded 4 4
Thermal Decomposition of Device 4 4
Sparking 4 4
No Flow 4 4
Failure to Shut Off 3 3
Break 3 3
Vibration 3 3
Accessory Incompatible 3 3
Crack 3 3
Melted 2 2
Energy Output Problem 2 2
Gas Output Problem 2 2
Inaccurate Delivery 2 2
Intermittent Loss of Power 2 2
Unintended Electrical Shock 1 1
Intermittent Energy Output 1 1
Suction Failure 1 1
Flare or Flash 1 1
Device Contamination with Chemical or Other Material 1 1
No Pressure 1 1
Material Integrity Problem 1 1
Physical Resistance/Sticking 1 1
Complete Loss of Power 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Device Displays Incorrect Message 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
Overheating of Device 1 1
Loss of Power 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Material Fragmentation 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 853 853
No Consequences Or Impact To Patient 139 139
No Patient Involvement 84 84
No Information 39 39
Insufficient Information 8 8
Low Oxygen Saturation 8 8
No Known Impact Or Consequence To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Cough 2 2
Dyspnea 2 2
Pneumonia 1 1
Underdose 1 1
Electric Shock 1 1
Wheezing 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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