TPLC - Total Product Life Cycle

• 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