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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, gas, oxygen, gaseous-phase
Regulation Description Oxygen gas analyzer.
Product CodeCCL
Regulation Number 868.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 5 5
2016 1 1
2017 2 2
2018 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Screen 1 1
Device Alarm System 1 1
Inaccurate Flow Rate 1 1
Device Inoperable 1 1
Insufficient Flow or Under Infusion 1 1
Device Displays Incorrect Message 1 1
Flowmeter 1 1
No Display/Image 1 1
Device Expiration Issue 1 1
Calibration Problem 1 1
Communication or Transmission Problem 1 1
Device Operates Differently Than Expected 1 1
Improper Flow or Infusion 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
No Code Available 1 1
Death 1 1
Respiratory Distress 1 1
No Patient Involvement 1 1
Hypersensitivity/Allergic reaction 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II May-28-2015
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