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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, breathing frequency
Regulation Description Breathing frequency monitor.
Product CodeBZQ
Regulation Number 868.2375
Device Class 2


Premarket Reviews
ManufacturerDecision
EARLYSENSE LTD.
  SUBSTANTIALLY EQUIVALENT 2
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PNEUMACARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 11 11
2018 10 10
2019 13 13
2020 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Speaker/Sounder 11 11
Device Alarm System 7 7
Defective Component 6 6
Screen 5 5
Device Inoperable 3 3
No Audible Alarm 3 3
Device Operates Differently Than Expected 3 3
Display or Visual Feedback Problem 2 2
No Device Output 2 2
Inaudible or Unclear Audible Prompt/Feedback 2 2
Device Displays Incorrect Message 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 2 2
Loss of Data 1 1
Monitor 1 1
Alarm Not Visible 1 1
Device Stops Intermittently 1 1
Defective Device 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
Mechanical Problem 1 1
Break 1 1
No Display/Image 1 1
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Delayed Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 25 25
No Patient Involvement 7 7
Death 5 5
Tachycardia 1 1
Complaint, Ill-Defined 1 1
Sore Throat 1 1
Low Oxygen Saturation 1 1
Cardiopulmonary Arrest 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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