TPLC - Total Product Life Cycle

• Device: monitor, breathing frequency
• Product Code: BZQ
• Regulation Number: 868.2375
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BAXTER HEALTHCARE CORPRORATION
	SUBSTANTIALLY EQUIVALENT	1
CIRCADIA TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	1
HILL-ROM, INC.
	SUBSTANTIALLY EQUIVALENT	1
LINSHOM MANAGEMENT LLC
	SUBSTANTIALLY EQUIVALENT	1
LINSHOM MEDICAL INC.
	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
2019	13	13
2020	10	10
2021	1	1
2022	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Component	6	6
Therapeutic or Diagnostic Output Failure	3	3
Device Alarm System	3	3
Device Fell	3	3
Inaudible or Unclear Audible Prompt/Feedback	2	2
Operating System Becomes Nonfunctional	1	1
Defective Device	1	1
Application Network Problem	1	1
Device Displays Incorrect Message	1	1
Display or Visual Feedback Problem	1	1
Break	1	1
Output Problem	1	1
Wireless Communication Problem	1	1
Delayed Alarm	1	1
Incorrect Measurement	1	1
Alarm Not Visible	1	1
No Audible Alarm	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	14	14
No Clinical Signs, Symptoms or Conditions	5	5
No Patient Involvement	4	4
Death	2	2
Tachycardia	1	1