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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
BAXTER HEALTHCARE CORPRORATION
  SUBSTANTIALLY EQUIVALENT 1
CIRCADIA TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
FACEHEART CORP.
  SUBSTANTIALLY EQUIVALENT 1
HEROIC FAITH INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINSHOM MANAGEMENT LLC
  SUBSTANTIALLY EQUIVALENT 1
LINSHOM MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKANI SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PMD SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
RESPIREE PTE LTD.
  SUBSTANTIALLY EQUIVALENT 1
RTM VITAL SIGNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOUND LIFE SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TURTLE SHELL TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 10 10
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 3 3
Therapeutic or Diagnostic Output Failure 3 3
Inaudible or Unclear Audible Prompt/Feedback 1 1
Device Alarm System 1 1
Wireless Communication Problem 1 1
Device Fell 1 1
Alarm Not Visible 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Incorrect Measurement 1 1
Application Network Problem 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Known Impact Or Consequence To Patient 4 4
No Patient Involvement 3 3
Death 1 1

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