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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

Device Problems
Inaccurate Delivery 21
Device Operates Differently Than Expected 12
No Audible Alarm 8
Device Alarm System 7
Out-Of-Box Failure 6
Leak / Splash 5
Output Problem 4
Mechanical Problem 4
Material Integrity Problem 4
No Apparent Adverse Event 3
Infusion or Flow Problem 2
False Alarm 2
Fire 2
Failure to Calibrate 2
Gas Leak 2
Valve, Flow 2
Break 1
Output above Specifications 1
Delayed Alarm 1
Device Sensing Problem 1
Misassembly during Maintenance / Repair 1
No Flow 1
High Readings 1
Therapeutic or Diagnostic Output Failure 1
Medical Gas Supply Problem 1
Calibration Problem 1
No Device Output 1
Defective Alarm 1
Total Device Problems 98

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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