TPLC - Total Product Life Cycle

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Device	transmitters and receivers, physiological signal, radiofrequency
Product Code	DRG
Regulation Number	870.2910
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALIO, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOINTELLISENSE INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOLNTELLISENSE INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BRAVEHEART WIRELESS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDIOLINE S.P.A
	SUBSTANTIALLY EQUIVALENT	1
CARETAKER MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
COMARCH HEALTHCARE SA
	SUBSTANTIALLY EQUIVALENT	1
ELASTIC CARE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
ERGOLINE GMBH
	SUBSTANTIALLY EQUIVALENT	1
GRAFTWORX, INC. DBA ALIO
	SUBSTANTIALLY EQUIVALENT	1
HMICRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
ISANSYS LIFECARE LTD
	SUBSTANTIALLY EQUIVALENT	1
LIFESIGNALS, INC.
	SUBSTANTIALLY EQUIVALENT	2
LR MED INC
	SUBSTANTIALLY EQUIVALENT	1
MC10 INC.
	SUBSTANTIALLY EQUIVALENT	1
MORTARA INSTRUMENT INC
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
ROOTI LABS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIBEL HEALTH INC.
	SUBSTANTIALLY EQUIVALENT	2
SIBEL INC.
	SUBSTANTIALLY EQUIVALENT	2
SIGKNOW BIOMEDICAL CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYNERGEN TECHNOLOGY LABS LLC
	SUBSTANTIALLY EQUIVALENT	1
UNITED HEALTH GROUP INC.
	SUBSTANTIALLY EQUIVALENT	1
VISICU INC.
	SUBSTANTIALLY EQUIVALENT	1
VITAL CONNECT, INC.
	SUBSTANTIALLY EQUIVALENT	1
VITALCONNECT, INC.
	SUBSTANTIALLY EQUIVALENT	5
VITLS INC.
	SUBSTANTIALLY EQUIVALENT	1
VIVALNK, INC.
	SUBSTANTIALLY EQUIVALENT	1
VIVIFY HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Communication or Transmission Problem	253	253
Thermal Decomposition of Device	245	245
Failure to Power Up	167	167
Adverse Event Without Identified Device or Use Problem	89	89
Power Conditioning Problem	46	46
Output Problem	35	35
Device Operates Differently Than Expected	29	29
Charred	28	28
Intermittent Communication Failure	22	22
Computer Software Problem	18	18
Loss of Power	18	18
Overheating of Device	16	16
Signal Artifact/Noise	14	14
Radio Signal Problem	14	14
Application Program Problem	11	11
No Display/Image	10	10
Power Problem	10	10
Incorrect, Inadequate or Imprecise Result or Readings	9	9
Smoking	9	9
Wireless Communication Problem	9	9
Temperature Problem	8	8
Protective Measures Problem	7	7
Appropriate Term/Code Not Available	7	7
Device Operational Issue	7	7
Break	7	7
Sparking	7	7
Device Inoperable	6	6
Melted	6	6
Device Alarm System	6	6
Device Issue	6	6
Computer System Security Problem	5	5
Incomplete or Inadequate Connection	5	5
Device Emits Odor	5	5
Unintended Application Program Shut Down	4	4
Device Displays Incorrect Message	4	4
Device Sensing Problem	4	4
Failure to Read Input Signal	4	4
Electrical /Electronic Property Problem	3	3
Radiofrequency Interference (RFI)	3	3
Computer Operating System Problem	3	3
Data Problem	3	3
Connection Problem	2	2
Incorrect Interpretation of Signal	2	2
Display or Visual Feedback Problem	2	2
Failure to Advance	2	2
Telemetry Discrepancy	2	2
Material Separation	2	2
Application Interface Becomes Non-Functional Or Program Exits Abnormally	2	2
No Audible Alarm	2	2
Invalid Sensing	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	640	640
No Clinical Signs, Symptoms or Conditions	253	253
No Consequences Or Impact To Patient	81	81
No Information	33	33
No Patient Involvement	13	13
Death	5	5
Insufficient Information	5	5
Electric Shock	2	2
Burn(s)	2	2
Shock	2	2
Ulceration	2	2
Contact Dermatitis	2	2
Partial thickness (Second Degree) Burn	2	2
Foreign Body In Patient	1	1
Unspecified Tissue Injury	1	1
Hypoxia	1	1
Tissue Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Biointellisense Inc.	II	Aug-14-2024
2	Boston Scientific Corporation	II	Sep-13-2017
3	Nihon Kohden America Inc	II	Mar-02-2021
4	Philips Visicu	II	Apr-04-2017
5	Vitalconnect Inc.	II	Jul-10-2020