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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transmitters and receivers, physiological signal, radiofrequency
Product CodeDRG
Regulation Number 870.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
AFRAME DIGITAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALCATEL-LUCENT CANADA INC.
  SUBSTANTIALLY EQUIVALENT 1
ALIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH
  SUBSTANTIALLY EQUIVALENT 1
ASCOT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BIOINTELLISENSE INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOLNTELLISENSE INC.
  SUBSTANTIALLY EQUIVALENT 1
BL HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRAVEHEART WIRELESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOCOM LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDIOLINE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
CAREFUSION 303, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREMATIX INC.
  SUBSTANTIALLY EQUIVALENT 1
CARETAKER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS
  SUBSTANTIALLY EQUIVALENT 1
CELLO PARTNERSHIP D/B/A VERIZON WIRELESS
  SUBSTANTIALLY EQUIVALENT 1
CERNER CORP.
  SUBSTANTIALLY EQUIVALENT 1
COMARCH HEALTHCARE SA
  SUBSTANTIALLY EQUIVALENT 1
CONFIDANT INC.
  SUBSTANTIALLY EQUIVALENT 1
CONSTANT CARE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CONTINUITY HEALTH SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
DIGIO2 INTERNATIONAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ELASTIC CARE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
EMERGO EUROPE CONSULTING BV
  SUBSTANTIALLY EQUIVALENT 1
ENTRA HEALTH SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ERGOLINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
EXPRESS MD SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GRAFTWORX, INC. DBA ALIO
  SUBSTANTIALLY EQUIVALENT 1
HEALTHANYWHERE, AN IGEACARE SYSTEM COMPANY
  SUBSTANTIALLY EQUIVALENT 1
HEALTHINTERLINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
HMICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
HONEYWELL HOMMED
  SUBSTANTIALLY EQUIVALENT 1
HONEYWELL HOMMED, LLC
  SUBSTANTIALLY EQUIVALENT 3
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMETRIKUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEL CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTEL CORPORATION DIGITAL HEALTH GROUP
  SUBSTANTIALLY EQUIVALENT 1
INTEL-GE CARE INNOVATIONS LLC
  SUBSTANTIALLY EQUIVALENT 2
INTOUCH HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
ISANSYS LIFECARE LTD
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
LIFELINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFESIGNALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LR MED INC
  SUBSTANTIALLY EQUIVALENT 1
MC10 INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDAPPS INC., DBA ALERE CONNECT
  SUBSTANTIALLY EQUIVALENT 2
MEDAPPS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICOMP, INC.
  SUBSTANTIALLY EQUIVALENT 2
MORTARA INSTRUMENT INC
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
OPTUMHEALTH CARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
POLYMAP WIRELESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROOTI LABS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SANITAS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIBEL HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
SIBEL INC.
  SUBSTANTIALLY EQUIVALENT 2
SIGKNOW BIOMEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 2
SYNERGEN TECHNOLOGY LABS LLC
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TELEMEDCARE PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
TUNSTALL HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
UNITED HEALTH GROUP INC.
  SUBSTANTIALLY EQUIVALENT 1
VIGNET INC.
  SUBSTANTIALLY EQUIVALENT 1
VISICU INC.
  SUBSTANTIALLY EQUIVALENT 1
VISICU, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL CONNECT INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL CONNECT, INC
  SUBSTANTIALLY EQUIVALENT 1
VITAL CONNECT, INC.
  SUBSTANTIALLY EQUIVALENT 2
VITALCONNECT, INC.
  SUBSTANTIALLY EQUIVALENT 5
VITLS INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVALNK, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVIFY HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOCARE, INC
  SUBSTANTIALLY EQUIVALENT 1
WALDO HEALTH
  SUBSTANTIALLY EQUIVALENT 1
WATERMARK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ZEPHYR TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 97 97
2015 130 130
2016 182 182
2017 484 484
2018 166 166
2019 70 70
2020 82 82
2021 107 107
2022 44 44
2023 19 19
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Thermal Decomposition of Device 336 336
Communication or Transmission Problem 279 279
Failure to Power Up 177 177
Device Operates Differently Than Expected 126 126
Adverse Event Without Identified Device or Use Problem 100 100
Power Conditioning Problem 85 85
Charred 82 82
Device Inoperable 56 56
Overheating of Device 48 48
Output Problem 35 35
Intermittent Communication Failure 22 22
Temperature Problem 21 21
Loss of Power 19 19
Melted 18 18
Computer Software Problem 17 17
Break 16 16
Wireless Communication Problem 16 16
Power Problem 16 16
No Display/Image 15 15
Radio Signal Problem 15 15
Smoking 14 14
Signal Artifact/Noise 14 14
Device Stops Intermittently 11 11
Noise, Audible 11 11
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Device Emits Odor 10 10
Application Program Problem 10 10
Sparking 10 10
Device Displays Incorrect Message 9 9
Device Operational Issue 8 8
Failure to Fire 7 7
Battery Problem 7 7
Appropriate Term/Code Not Available 7 7
Protective Measures Problem 7 7
Device Issue 7 7
Device Alarm System 7 7
Electrical /Electronic Property Problem 6 6
Data Problem 5 5
Device Sensing Problem 5 5
Failure to Read Input Signal 5 5
Radiofrequency Interference (RFI) 5 5
Fire 5 5
Computer Operating System Problem 5 5
Incomplete or Inadequate Connection 5 5
Burst Container or Vessel 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Defective Component 3 3
Computer System Security Problem 3 3
Unintended Application Program Shut Down 3 3
Connection Problem 3 3
Electrical Shorting 3 3
Display or Visual Feedback Problem 3 3
Crack 2 2
Split 2 2
Low Battery 2 2
Moisture Damage 2 2
Device Markings/Labelling Problem 2 2
Improper Alarm 2 2
Image Display Error/Artifact 2 2
Detachment Of Device Component 2 2
Material Separation 2 2
Telemetry Discrepancy 2 2
Incorrect Interpretation of Signal 2 2
Patient Data Problem 2 2
Invalid Sensing 2 2
Premature Discharge of Battery 2 2
Failure to Transmit Record 2 2
Inappropriate or Unexpected Reset 2 2
No Audible Alarm 2 2
Incorrect Measurement 2 2
Programming Issue 2 2
Operating System Becomes Nonfunctional 2 2
Unintended Electrical Shock 2 2
False Alarm 2 2
Failure to Advance 2 2
Loss of Data 2 2
Charging Problem 1 1
Material Integrity Problem 1 1
Issue With Displayed Error Message 1 1
Application Program Problem: Parameter Calculation Error 1 1
Product Quality Problem 1 1
Failure To Service 1 1
Corroded 1 1
Failure to Capture 1 1
Material Discolored 1 1
Improper or Incorrect Procedure or Method 1 1
Electronic Property Issue 1 1
Application Program Version or Upgrade Problem 1 1
Failure to Cycle 1 1
Water softener regeneration cycle, mistiming of 1 1
Measurement System Incompatibility 1 1
Application Security Problem 1 1
No Apparent Adverse Event 1 1
Therapeutic or Diagnostic Output Failure 1 1
Component Missing 1 1
Failure to Interrogate 1 1
Circuit Failure 1 1
High Readings 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 961 961
No Clinical Signs, Symptoms or Conditions 248 248
No Consequences Or Impact To Patient 136 136
No Information 41 41
No Patient Involvement 29 29
Death 6 6
Burn(s) 6 6
Shock 4 4
Insufficient Information 4 4
Electric Shock 3 3
Ulceration 2 2
Weight Changes 2 2
Contact Dermatitis 2 2
Partial thickness (Second Degree) Burn 2 2
Shock from Patient Lead(s) 2 2
Missing Value Reason 1 1
Unspecified Tissue Injury 1 1
Weakness 1 1
Complaint, Ill-Defined 1 1
Burn, Thermal 1 1
Diminished Pulse Pressure 1 1
Foreign Body In Patient 1 1
Tissue Damage 1 1
Cardiac Arrest 1 1
Fall 1 1
Hypoxia 1 1
Pain 1 1
Scar Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BRAEMAR, INC. II Jul-02-2013
2 BRAEMAR, INC. II Jul-02-2013
3 Boston Scientific Corporation II Sep-13-2017
4 Nihon Kohden America Inc II Mar-02-2021
5 Philips Visicu II Apr-04-2017
6 Philips Visicu II Apr-22-2016
7 Vitalconnect Inc. II Jul-10-2020
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