Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device ventilator, high frequency
Product CodeLSZ
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
3 3 2 3 2 1

MDR Year MDR Reports MDR Events
2018 88 88
2019 88 88
2020 154 154
2021 224 224
2022 220 220
2023 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 520 520
Pressure Problem 61 61
Device Operates Differently Than Expected 44 44
Leak/Splash 23 23
Device Stops Intermittently 17 17
Overheating of Device 13 13
Disconnection 12 12
Failure to Cycle 11 11
Material Too Soft/Flexible 11 11
Infusion or Flow Problem 9 9
Temperature Problem 8 8
Connection Problem 7 7
Improper Flow or Infusion 7 7
Loose or Intermittent Connection 7 7
Fluid/Blood Leak 6 6
Display or Visual Feedback Problem 6 6
Device Alarm System 6 6
No Audible Alarm 6 6
Calibration Problem 6 6
Unexpected Shutdown 6 6
Therapeutic or Diagnostic Output Failure 5 5
Appropriate Term/Code Not Available 5 5
Insufficient Heating 5 5
Smoking 5 5
Decrease in Pressure 4 4
Noise, Audible 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Device Displays Incorrect Message 4 4
Defective Component 4 4
Power Problem 4 4
High Readings 3 3
Insufficient Information 3 3
Failure to Power Up 3 3
Product Quality Problem 3 3
Break 3 3
Thermal Decomposition of Device 2 2
Circuit Failure 2 2
Crack 2 2
Electrical /Electronic Property Problem 2 2
Defective Alarm 2 2
Inaccurate Flow Rate 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Increase in Pressure 2 2
Loss of Power 2 2
Protective Measures Problem 2 2
Overfill 2 2
Failure to Calibrate 1 1
High Test Results 1 1
Component Missing 1 1
Tidal Volume Fluctuations 1 1
Insufficient Flow or Under Infusion 1 1
No Audible Prompt/Feedback 1 1
Failure to Align 1 1
Defective Device 1 1
Electrical Power Problem 1 1
Mechanical Jam 1 1
Moisture or Humidity Problem 1 1
No Pressure 1 1
Output below Specifications 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 1
Complete Loss of Power 1 1
Intermittent Loss of Power 1 1
Melted 1 1
Device Emits Odor 1 1
Fracture 1 1
Gas Output Problem 1 1
Incorrect Measurement 1 1
Failure to Pump 1 1
Failure to Recalibrate 1 1
Filling Problem 1 1
Unintended Power Up 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Alarm Not Visible 1 1
False Alarm 1 1
Excessive Heating 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Suction Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 514 514
No Consequences Or Impact To Patient 123 123
No Patient Involvement 95 95
No Information 32 32
No Known Impact Or Consequence To Patient 25 25
Low Oxygen Saturation 19 19
Bradycardia 8 8
Insufficient Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Hypoventilation 4 4
Pneumothorax 4 4
Hypoxia 3 3
Death 3 3
Aspiration/Inhalation 3 3
Respiratory Acidosis 2 2
Respiratory Failure 2 2
Diminished Pulse Pressure 1 1
No Code Available 1 1
Abnormal Blood Gases 1 1
Lethargy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bunnell, Inc. II Dec-03-2022
-
-