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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
Product CodeBZR
Regulation Number 868.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
ATOM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BALDUS SEDATION GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH 207, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEHAS MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
GENTEC (SHANGHAI) CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LINDE HEALTHCARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 2
O-TWO MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
O-TWO MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARKER HANNIFIN
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 11 11
2015 39 39
2016 30 30
2017 22 22
2018 24 24
2019 26 26
2020 15 15
2021 33 33
2022 15 15
2023 19 19
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 39 39
Inaccurate Delivery 32 32
Device Operates Differently Than Expected 29 29
No Audible Alarm 20 20
Device Alarm System 17 17
Leak/Splash 17 17
Output Problem 8 8
Infusion or Flow Problem 7 7
Out-Of-Box Failure 6 6
Defective Device 5 5
Fire 5 5
Therapeutic or Diagnostic Output Failure 5 5
No Apparent Adverse Event 4 4
Failure to Calibrate 4 4
Gas Output Problem 4 4
No Flow 4 4
Material Integrity Problem 4 4
Improper Device Output 4 4
Calibration Problem 4 4
Loose or Intermittent Connection 3 3
Protective Measures Problem 3 3
False Alarm 3 3
Medical Gas Supply Problem 3 3
Gas/Air Leak 3 3
Contamination 2 2
Failure to Deliver 2 2
Appropriate Term/Code Not Available 2 2
Output above Specifications 2 2
Excess Flow or Over-Infusion 2 2
Delayed Alarm 2 2
Positioning Problem 2 2
Improper Flow or Infusion 2 2
Insufficient Information 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Slipped 1 1
No Device Output 1 1
Incorrect Or Inadequate Test Results 1 1
Break 1 1
Failure to Align 1 1
Display or Visual Feedback Problem 1 1
Crack 1 1
Naturally Worn 1 1
No Audible Prompt/Feedback 1 1
Disconnection 1 1
Volume Accuracy Problem 1 1
Defective Alarm 1 1
Insufficient Flow or Under Infusion 1 1
Misassembly During Maintenance/Repair 1 1
Free or Unrestricted Flow 1 1
Kinked 1 1
Device Damaged by Another Device 1 1
Use of Incorrect Control/Treatment Settings 1 1
Pressure Problem 1 1
Material Frayed 1 1
Device Displays Incorrect Message 1 1
High Readings 1 1
Melted 1 1
Incorrect Measurement 1 1
Misconnection 1 1
Device Sensing Problem 1 1
Material Twisted/Bent 1 1
Programming Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 99 99
No Clinical Signs, Symptoms or Conditions 58 58
Low Oxygen Saturation 24 24
No Known Impact Or Consequence To Patient 20 20
No Consequences Or Impact To Patient 11 11
No Information 7 7
Insufficient Information 7 7
Superficial (First Degree) Burn 2 2
Respiratory Distress 2 2
Retinal Injury 1 1
Complaint, Ill-Defined 1 1
Abnormal Blood Gases 1 1
Death 1 1
Hypoxia 1 1
Overdose 1 1
High Oxygen Saturation 1 1
Abdominal Distention 1 1
No Code Available 1 1
Respiratory Arrest 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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