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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


Premarket Reviews
ManufacturerDecision
EKOM S.R.O.
  SUBSTANTIALLY EQUIVALENT 1
ORICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRUDELL MEDICAL INTL.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 982 982
2015 294 294
2016 139 139
2017 102 102
2018 71 71
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 582 582
Device Inoperable 255 255
Output Problem 250 250
Improper Flow or Infusion 233 233
Device Operates Differently Than Expected 204 204
Decrease in Pressure 177 177
Pressure Problem 108 108
Noise, Audible 83 83
Electrical /Electronic Property Problem 73 73
Break 69 69
Product Quality Problem 68 68
Loss of Power 67 67
No Device Output 61 61
Device Displays Incorrect Message 54 54
No Pressure 51 51
Failure to Deliver 49 49
Mechanical Problem 48 48
No Flow 39 39
Device Stops Intermittently 32 32
Contamination /Decontamination Problem 22 22
Electronic Property Issue 20 20
Power Problem 20 20
Output below Specifications 19 19
Leak/Splash 18 18
Smoking 18 18
Infusion or Flow Problem 17 17
Appropriate Term/Code Not Available 13 13
Insufficient Information 12 12
Fire 12 12
Increase in Pressure 11 11
Unexpected Shutdown 11 11
Material Split, Cut or Torn 11 11
Moisture or Humidity Problem 11 11
Overheating of Device 9 9
Sticking 8 8
Device Alarm System 8 8
Contamination 8 8
Crack 8 8
Defective Device 8 8
Gas/Air Leak 8 8
Improper Device Output 8 8
Thermal Decomposition of Device 7 7
Inaccurate Delivery 7 7
Sparking 7 7
Hole In Material 6 6
Temperature Problem 6 6
Intermittent Loss of Power 5 5
Peeled/Delaminated 5 5
Unstable 5 5
Insufficient Flow or Under Infusion 5 5
Detachment Of Device Component 5 5
Circuit Failure 4 4
Degraded 4 4
Failure to Shut Off 4 4
Inaccurate Dispensing 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Melted 3 3
Device Emits Odor 3 3
Failure To Run On AC/DC 3 3
Accessory Incompatible 3 3
Vibration 3 3
Power Conditioning Problem 2 2
Self-Activation or Keying 2 2
No Audible Alarm 2 2
Energy Output Problem 2 2
Loose or Intermittent Connection 2 2
Device Maintenance Issue 2 2
Material Frayed 2 2
Fluid/Blood Leak 2 2
Electrical Shorting 2 2
Failure of Device to Self-Test 2 2
Computer Operating System Problem 2 2
Arcing 2 2
Physical Resistance/Sticking 2 2
Complete Loss of Power 1 1
Unintended Electrical Shock 1 1
Application Program Problem: Medication Error 1 1
Device Handling Problem 1 1
Intermittent Energy Output 1 1
Suction Failure 1 1
Difficult to Open or Close 1 1
Electrical Power Problem 1 1
Connection Problem 1 1
Delivery System Failure 1 1
Detachment of Device or Device Component 1 1
Flare or Flash 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Medical Gas Supply Problem 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Physical Property Issue 1 1
Fracture 1 1
Material Fragmentation 1 1
Unintended Power Up 1 1
Disconnection 1 1
Unintended Ejection 1 1
Gas Output Problem 1 1
Signal Artifact/Noise 1 1
Bent 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 831 831
No Known Impact Or Consequence To Patient 554 554
No Patient Involvement 311 311
No Information 124 124
Missed Dose 12 12
Low Oxygen Saturation 8 8
Insufficient Information 7 7
Asthma 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Underdose 3 3
Respiratory Distress 3 3
Death 3 3
Dyspnea 3 3
Cough 2 2
Wheezing 1 1
Unspecified Respiratory Problem 1 1
No Code Available 1 1
Electric Shock 1 1
Electrocution 1 1
Fall 1 1
Hypoventilation 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Irritation 1 1
Pneumonia 1 1
Urinary Retention 1 1
Burn(s) 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Discomfort 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Datex-Ohmeda, Inc. I Jan-30-2024
2 Maquet Cardiovascular Us Sales, Llc II Jan-28-2014
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