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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spirometer, monitoring (w/wo alarm)
Product CodeBZK
Regulation Number 868.1850
Device Class 2


Premarket Reviews
ManufacturerDecision
MERMAID CARE A/S
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY MOTION
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY MOTION INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 12 12
2016 1 1
2017 1 1
2018 1 1
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 11 11
No Apparent Adverse Event 2 2
Improper Device Output 1 1
Break 1 1
Output Problem 1 1
Excess Flow or Over-Infusion 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11 11
No Consequences Or Impact To Patient 3 3
Sudden Cardiac Death 2 2
Dizziness 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mindray DS USA, Inc. dba Mindray North America III Mar-28-2018
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