TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
BIOINTELLISENSE INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOLNTELLISENSE INC.
	SUBSTANTIALLY EQUIVALENT	1
BRAVEHEART WIRELESS, INC.
	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
MC10 INC.
	SUBSTANTIALLY EQUIVALENT	1
MORTARA INSTRUMENT INC
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
SIBEL INC.
	SUBSTANTIALLY EQUIVALENT	2
SIGKNOW BIOMEDICAL CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYNERGEN TECHNOLOGY LABS LLC
	SUBSTANTIALLY EQUIVALENT	1
VITALCONNECT, INC.
	SUBSTANTIALLY EQUIVALENT	4
VITLS INC.
	SUBSTANTIALLY EQUIVALENT	1
VIVALNK, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	166	166
2019	70	70
2020	82	82
2021	107	107
2022	44	44

Device Problems	MDRs with this Device Problem	Events in those MDRs
Communication or Transmission Problem	214	214
Thermal Decomposition of Device	76	76
Failure to Power Up	47	47
Output Problem	29	29
Adverse Event Without Identified Device or Use Problem	24	24
Intermittent Communication Failure	17	17
Loss of Power	16	16
Computer Software Problem	14	14
Signal Artifact/Noise	11	11
Application Program Problem	10	10
Power Problem	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Smoking	7	7
Overheating of Device	6	6
Appropriate Term/Code Not Available	6	6
Device Issue	6	6
Sparking	5	5
Protective Measures Problem	5	5
Incomplete or Inadequate Connection	5	5
Device Operational Issue	4	4
Break	4	4
Device Alarm System	4	4
Charred	3	3
No Display/Image	3	3
Temperature Problem	3	3
Device Emits Odor	3	3
Radio Signal Problem	3	3
Unintended Application Program Shut Down	3	3
Radiofrequency Interference (RFI)	2	2
Wireless Communication Problem	2	2
Unintended Electrical Shock	2	2
Incorrect Interpretation of Signal	2	2
Operating System Becomes Nonfunctional	2	2
Display or Visual Feedback Problem	2	2
Melted	2	2
Connection Problem	2	2
Device Difficult to Maintain	1	1
Complete Loss of Power	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Electrical /Electronic Property Problem	1	1
Moisture Damage	1	1
Material Rupture	1	1
High Readings	1	1
Device Displays Incorrect Message	1	1
Biocompatibility	1	1
No Audible Alarm	1	1
Filtration Problem	1	1
Incorrect Measurement	1	1
Patient Data Problem	1	1
Application Program Version or Upgrade Problem	1	1
Application Security Problem	1	1
Device Operates Differently Than Expected	1	1
Material Separation	1	1
Telemetry Discrepancy	1	1
Image Display Error/Artifact	1	1
Application Program Problem: Parameter Calculation Error	1	1
Power Conditioning Problem	1	1
Device Inoperable	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Device Sensing Problem	1	1
Improper Alarm	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	208	208
No Known Impact Or Consequence To Patient	183	183
No Consequences Or Impact To Patient	68	68
No Information	27	27
Death	4	4
No Patient Involvement	4	4
Insufficient Information	3	3
Partial thickness (Second Degree) Burn	2	2
Contact Dermatitis	2	2
Electric Shock	2	2
Unspecified Tissue Injury	1	1
Hypoxia	1	1
Shock	1	1
Tissue Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Nihon Kohden America Inc	II	Mar-02-2021
2	Vitalconnect Inc.	II	Jul-10-2020