TPLC - Total Product Life Cycle

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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
ASCOM SWEDEN AB
	SUBSTANTIALLY EQUIVALENT	1
ASCOM UMS SRL UNIPERSONALE
	SUBSTANTIALLY EQUIVALENT	1
ATHENA GTX
	SUBSTANTIALLY EQUIVALENT	1
BIOFOURMIS SINGAPORE PTE. LTD
	SUBSTANTIALLY EQUIVALENT	1
BOXVIEW, LLC
	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	1
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
SNAP40 LTD
	SUBSTANTIALLY EQUIVALENT	1
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	27	27
No Audible Alarm	25	25
Alarm Not Visible	10	10
Delayed Alarm	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Defective Alarm	3	3
Device Operational Issue	3	3
Disconnection	2	2
Fire	2	2
Improper or Incorrect Procedure or Method	2	2
Output Problem	2	2
Device Operates Differently Than Expected	2	2
Communication or Transmission Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Wireless Communication Problem	2	2
No Visual Prompts/Feedback	2	2
Application Program Freezes, Becomes Nonfunctional	1	1
Intermittent Communication Failure	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Patient Data Problem	1	1
Device Handling Problem	1	1
Noise, Audible	1	1
Connection Problem	1	1
Positioning Problem	1	1
Protective Measures Problem	1	1
Operating System Becomes Nonfunctional	1	1
High Readings	1	1
Inappropriate Waveform	1	1
Device Displays Incorrect Message	1	1
Application Network Problem	1	1
Melted	1	1
Misconnection	1	1
Failure to Transmit Record	1	1
Device Slipped	1	1
Smoking	1	1
Use of Device Problem	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Computer Software Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20	20
Insufficient Information	17	17
No Known Impact Or Consequence To Patient	17	17
Death	14	14
No Consequences Or Impact To Patient	11	11
Cardiopulmonary Arrest	4	4
Cardiac Arrest	3	3
Asystole	3	3
Low Oxygen Saturation	2	2
Bradycardia	2	2
Chest Pain	2	2
Dyspnea	1	1
Low Blood Pressure/ Hypotension	1	1
Ventricular Tachycardia	1	1
Sudden Cardiac Death	1	1
Loss Of Pulse	1	1
No Patient Involvement	1	1
Respiratory Arrest	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	Mindray DS USA, Inc. dba Mindray North America	II	Feb-08-2018
4	Philips North America Llc	II	Feb-01-2022
5	Spacelabs Healthcare Inc	II	Jan-25-2018