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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
Product CodeCCL
Regulation Number 868.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREOX, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENVITEC-WISMAR GMBH
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 3
PRECISION MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 8 8
2015 5 5
2016 1 1
2017 2 2
2018 1 1
2019 1 1
2020 1 1
2021 3 3
2023 4 4
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Flow or Under Infusion 3 3
Insufficient Information 2 2
Device Inoperable 2 2
Device Operates Differently Than Expected 2 2
Device Displays Incorrect Message 2 2
High Readings 1 1
Application Program Problem: Dose Calculation Error 1 1
Incorrect Measurement 1 1
No Apparent Adverse Event 1 1
No Display/Image 1 1
Failure to Deliver 1 1
Sparking 1 1
Communication or Transmission Problem 1 1
Device Sensing Problem 1 1
Inaccurate Flow Rate 1 1
Material Integrity Problem 1 1
Calibration Problem 1 1
Device Expiration Issue 1 1
Improper Flow or Infusion 1 1
Output Problem 1 1
Defective Device 1 1
Failure to Analyze Signal 1 1
Device Alarm System 1 1
Partial Blockage 1 1
Leak/Splash 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 5 5
No Information 4 4
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 2 2
Death 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Hypersensitivity/Allergic reaction 1 1
Respiratory Distress 1 1
Misdiagnosis 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II May-28-2015
2 GE Healthcare, LLC II Sep-09-2014
3 GE Healthcare, LLC II Jun-17-2014
4 Teleflex Medical II Dec-29-2009
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