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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mixer, breathing gases, anesthesia inhalation
Regulation Description Breathing gas mixer.
Product CodeBZR
Regulation Number 868.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
GENTEC (SHANGHAI) CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 39 39
2016 30 30
2017 22 22
2018 24 24
2019 26 26
2020 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Inaccurate Delivery 28 28
Device Operates Differently Than Expected 28 28
No Audible Alarm 16 16
Device Alarm System 14 14
Leak/Splash 10 10
Mechanical Problem 8 8
Out-Of-Box Failure 6 6
Infusion or Flow Problem 5 5
Output Problem 4 4
Calibration Problem 4 4
Failure to Calibrate 4 4
Improper Device Output 4 4
Material Integrity Problem 4 4
False Alarm 3 3
Loose or Intermittent Connection 3 3
No Apparent Adverse Event 3 3
Therapeutic or Diagnostic Output Failure 2 2
No Flow 2 2
Gas Leak 2 2
Excess Flow or Over-Infusion 2 2
Fire 2 2
Valve, Flow 2 2
Delayed Alarm 2 2
Tube 1 1
Ring 1 1
Gas Output Problem 1 1
Break 1 1
Incorrect Measurement 1 1
Incorrect Or Inadequate Test Results 1 1
No Device Output 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Device Slipped 1 1
Improper Flow or Infusion 1 1
Programming Issue 1 1
Protective Measures Problem 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Hose 1 1
Insufficient Information 1 1
Misconnection 1 1
Output above Specifications 1 1
High Readings 1 1
Device Displays Incorrect Message 1 1
Device Sensing Problem 1 1
Free or Unrestricted Flow 1 1
Defective Alarm 1 1
Disconnection 1 1
Kinked 1 1
Medical Gas Supply Problem 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Cannula 1 1
Misassembly During Maintenance/Repair 1 1
Knob 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 97 97
No Known Impact Or Consequence To Patient 16 16
Low Oxygen Saturation 12 12
No Consequences Or Impact To Patient 11 11
No Information 6 6
Abnormal Blood Gases 1 1
Death 1 1
Overdose 1 1
Respiratory Distress 1 1
Retinal Injury 1 1
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CAREstream Medical LLC II Aug-22-2018
2 O-Two Medical Technologies, Inc. II Aug-22-2018
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