TPLC - Total Product Life Cycle

show TPLC since

Device	system, network and communication, physiological monitors
Product Code	MSX
Regulation Number	870.2300
Device Class	2

Premarket Reviews
Manufacturer	Decision
AIRSTRIP TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALERTWATCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOFOURMIS SINGAPORE PTE. LTD
	SUBSTANTIALLY EQUIVALENT	1
BIOFOURMIS SINGAPORE PTE. LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOXVIEW, LLC
	SUBSTANTIALLY EQUIVALENT	1
CORSANO HEALTH B.V.
	SUBSTANTIALLY EQUIVALENT	1
CRITICAL ALERT
	SUBSTANTIALLY EQUIVALENT	1
CURRENT HEALTH
	SUBSTANTIALLY EQUIVALENT	1
CURRENT HEALTH LTD
	SUBSTANTIALLY EQUIVALENT	2
CURRENT HEALTH LTD.
	SUBSTANTIALLY EQUIVALENT	2
DRAEGER MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SPIRE, INC. D/B/A SPIRE HEALTH
	SUBSTANTIALLY EQUIVALENT	1
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VISICU, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZYTER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Alarm System	38	38
No Audible Alarm	29	29
Alarm Not Visible	9	9
Defective Alarm	5	5
Delayed Alarm	4	4
Wireless Communication Problem	3	3
Disconnection	2	2
Fire	2	2
Communication or Transmission Problem	2	2
Output Problem	2	2
No Visual Prompts/Feedback	2	2
Therapeutic or Diagnostic Output Failure	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Intermittent Communication Failure	2	2
Operating System Becomes Nonfunctional	1	1
Inappropriate Waveform	1	1
Insufficient Information	1	1
Failure to Transmit Record	1	1
Smoking	1	1
Positioning Problem	1	1
Patient Data Problem	1	1
High Readings	1	1
Unintended Application Program Shut Down	1	1
Use of Incorrect Control/Treatment Settings	1	1
Misconnection	1	1
Device Handling Problem	1	1
Low Audible Alarm	1	1
Computer Software Problem	1	1
Protective Measures Problem	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Melted	1	1
Application Network Problem	1	1
Connection Problem	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	30	30
Insufficient Information	29	29
No Known Impact Or Consequence To Patient	15	15
No Consequences Or Impact To Patient	7	7
Death	6	6
Cardiac Arrest	4	4
Asystole	4	4
Cardiopulmonary Arrest	3	3
Chest Pain	2	2
Low Oxygen Saturation	2	2
Respiratory Arrest	1	1
Ventricular Tachycardia	1	1
Loss Of Pulse	1	1
No Patient Involvement	1	1
Dyspnea	1	1
Bradycardia	1	1
Sudden Cardiac Death	1	1
Tachycardia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mindray DS USA, Inc. dba Mindray North America	III	Jul-21-2021
2	Mindray DS USA, Inc. dba Mindray North America	II	Mar-15-2021
3	Philips North America	II	Mar-27-2024
4	Philips North America Llc	II	Feb-01-2022