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TPLC
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Device
spirometer, monitoring (w/wo alarm)
Product Code
BZK
Regulation Number
868.1850
Device Class
2
Premarket Reviews
Manufacturer
Decision
MERMAID CARE A/S
SUBSTANTIALLY EQUIVALENT
1
NSPIRE HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
RESPIRATORY MOTION
SUBSTANTIALLY EQUIVALENT
1
RESPIRATORY MOTION INC.
SUBSTANTIALLY EQUIVALENT
2
RESPIRATORY MOTION, INC.
SUBSTANTIALLY EQUIVALENT
2
RESPIRONICS NOVAMETRIX LLC
SUBSTANTIALLY EQUIVALENT
1
RESPIRONICS NOVAMETRIX, INC.
SUBSTANTIALLY EQUIVALENT
1
RESPIRONICS NOVAMETRIX, LLC
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
31
31
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
36
36
Device Displays Incorrect Message
2
2
No Apparent Adverse Event
2
2
Connection Problem
1
1
Improper Device Output
1
1
Medical Gas Supply Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Break
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
False Reading From Device Non-Compliance
1
1
Excess Flow or Over-Infusion
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
29
29
No Consequences Or Impact To Patient
15
15
Sudden Cardiac Death
2
2
Fall
1
1
Dizziness
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mindray DS USA, Inc. dba Mindray North America
III
Mar-28-2018
2
Respironics Novametrix, LLC.
II
Sep-30-2011
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