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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
Product CodeBZQ
Regulation Number 868.2375
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPRORATION
  SUBSTANTIALLY EQUIVALENT 1
CIRCADIA TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
EARLYSENSE LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K171836  EarlySense Bed Sensing Unit
HILL-ROM INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINSHOM MANAGEMENT LLC
  SUBSTANTIALLY EQUIVALENT 1
LINSHOM MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PMD SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
RESPIREE PTE LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN FIBER MEDICAL TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOUND LIFE SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TURTLE SHELL TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 10 10
2019 13 13
2020 10 10
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 7 7
Defective Component 6 6
Therapeutic or Diagnostic Output Failure 3 3
Device Fell 3 3
Inaudible or Unclear Audible Prompt/Feedback 2 2
Display or Visual Feedback Problem 2 2
Device Displays Incorrect Message 2 2
Application Network Problem 1 1
Computer Operating System Problem 1 1
Loss of Data 1 1
Device Operates Differently Than Expected 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
No Audible Alarm 1 1
Alarm Not Visible 1 1
Break 1 1
No Display/Image 1 1
Delayed Alarm 1 1
Defective Device 1 1
Insufficient Information 1 1
Wireless Communication Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 20 20
Death 5 5
No Clinical Signs, Symptoms or Conditions 5 5
No Patient Involvement 4 4
Cardiopulmonary Arrest 1 1
Tachycardia 1 1

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