TPLC - Total Product Life Cycle

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Device	transmitters and receivers, physiological signal, radiofrequency
Regulation Description	Radiofrequency physiological signal transmitter and receiver.
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
CARDIOLINE S.P.A
	SUBSTANTIALLY EQUIVALENT	1
ELASTIC CARE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
ERGOLINE GMBH
	SUBSTANTIALLY EQUIVALENT	1
GRAFTWORX, INC. DBA ALIO
	SUBSTANTIALLY EQUIVALENT	1
IORBIT DIGITAL TECHNOLOGIES PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
LIFESIGNALS, INC.
	SUBSTANTIALLY EQUIVALENT	3
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
SIBEL HEALTH INC.
	SUBSTANTIALLY EQUIVALENT	2
SIBEL INC.
	SUBSTANTIALLY EQUIVALENT	2
SIGKNOW BIOMEDICAL CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
THE SCOTTCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VITALCONNECT, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	190	190
Output Problem	36	36
Intermittent Communication Failure	21	21
Computer Software Problem	18	18
Signal Artifact/Noise	14	14
Application Program Problem	11	11
Incorrect, Inadequate or Imprecise Result or Readings	9	9
Power Problem	8	8
Protective Measures Problem	7	7
No Display/Image	5	5
Incomplete or Inadequate Connection	5	5
Computer System Security Problem	5	5
Device Alarm System	4	4
Display or Visual Feedback Problem	4	4
Unintended Application Program Shut Down	4	4
Data Problem	3	3
Loss of Power	3	3
Computer Operating System Problem	3	3
No Audible Alarm	2	2
Appropriate Term/Code Not Available	2	2
Failure to Power Up	2	2
Connection Problem	2	2
Failure to Read Input Signal	1	1
Smoking	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Operating System Becomes Nonfunctional	1	1
Temperature Problem	1	1
No Apparent Adverse Event	1	1
Patient Data Problem	1	1
Intermittent Loss of Power	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Labelling, Instructions for Use or Training Problem	1	1
Overheating of Device	1	1
Application Program Problem: Parameter Calculation Error	1	1
Device Displays Incorrect Message	1	1
Biocompatibility	1	1
Filtration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	263	263
No Known Impact Or Consequence To Patient	24	24
No Consequences Or Impact To Patient	23	23
Insufficient Information	5	5
Death	3	3
Contact Dermatitis	2	2
Partial thickness (Second Degree) Burn	2	2
Tissue Damage	1	1
Unspecified Tissue Injury	1	1
Hypoxia	1	1
No Patient Involvement	1	1