• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device transmitters and receivers, physiological signal, radiofrequency
Regulation Description Radiofrequency physiological signal transmitter and receiver.
Product CodeDRG
Regulation Number 870.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOINTELLISENSE INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRAVEHEART WIRELESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARETAKER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
COMARCH HEALTHCARE SA
  SUBSTANTIALLY EQUIVALENT 1
HMICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
HONEYWELL HOMMED, LLC
  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
MEDICOMP, INC.
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT INC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ROOTI LABS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIBEL INC.
  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

MDR Year MDR Reports MDR Events
2016 182 182
2017 484 484
2018 166 166
2019 70 70
2020 82 82
2021 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Thermal Decomposition of Device 279 279
Communication or Transmission Problem 207 207
Failure to Power Up 173 173
Adverse Event Without Identified Device or Use Problem 93 93
Device Operates Differently Than Expected 81 81
Charred 58 58
Power Conditioning Problem 57 57
Overheating of Device 32 32
Device Inoperable 23 23
Output Problem 21 21
Intermittent Communication Failure 16 16
Loss of Power 16 16
Radio Signal Problem 14 14
Break 14 14
Temperature Problem 14 14
Wireless Communication Problem 12 12
No Display/Image 11 11
Smoking 10 10
Sparking 10 10
Power Problem 10 10
Device Operational Issue 8 8
Signal Artifact/Noise 8 8
Computer Software Problem 7 7
Incorrect, Inadequate or Imprecise Resultor Readings 7 7
Melted 7 7
Device Issue 7 7
Appropriate Term/Code Not Available 7 7
Device Displays Incorrect Message 6 6
Device Emits Odor 6 6
Electrical /Electronic Property Problem 5 5
Noise, Audible 5 5
Incomplete or Inadequate Connection 4 4
Device Alarm System 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Failure to Read Input Signal 4 4
Device Sensing Problem 4 4
Battery Problem 3 3
Application Program Problem 3 3
Radiofrequency Interference (RFI) 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Fire 3 3
Incorrect Interpretation of Signal 2 2
Display or Visual Feedback Problem 2 2
False Alarm 2 2
Defective Component 2 2
Invalid Sensing 2 2
Failure to Advance 2 2
Material Separation 2 2
Device Stops Intermittently 2 2
Telemetry Discrepancy 2 2
Computer Operating System Problem 2 2
Connection Problem 2 2
Improper Alarm 2 2
Inappropriate or Unexpected Reset 2 2
Electrical Shorting 2 2
Unintended Electrical Shock 2 2
Device Markings/Labelling Problem 2 2
Unintended Application Program Shut Down 2 2
Programming Issue 2 2
Operating System Becomes Nonfunctional 2 2
Therapeutic or Diagnostic Output Failure 1 1
Device Difficult to Maintain 1 1
Protective Measures Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Complete Loss of Power 1 1
Electronic Property Issue 1 1
Expulsion 1 1
Filtration Problem 1 1
Issue With Displayed Error Message 1 1
Biocompatibility 1 1
Charging Problem 1 1
Loss of Data 1 1
Application Program Version or Upgrade Problem 1 1
Application Security Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure To Service 1 1
Cut In Material 1 1
High Readings 1 1
Alarm Not Visible 1 1
Circuit Failure 1 1
Component Falling 1 1
Burst Container or Vessel 1 1
Crack 1 1
Failure to Cycle 1 1
Material Discolored 1 1
Disconnection 1 1
Material Rupture 1 1
Failure to Transmit Record 1 1
Product Quality Problem 1 1
Material Frayed 1 1
Image Display Error/Artifact 1 1
Failure to Interrogate 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Moisture Damage 1 1
Application Program Problem: Parameter Calculation Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 769 769
No Consequences Or Impact To Patient 123 123
No Clinical Signs, Symptoms or Conditions 120 120
No Information 38 38
No Patient Involvement 16 16
Death 6 6
Burn(s) 4 4
Electric Shock 3 3
Insufficient Information 3 3
Shock from Patient Lead(s) 2 2
Contact Dermatitis 2 2
Ulceration 2 2
Shock 2 2
Tissue Damage 1 1
Cardiac Arrest 1 1
Fall 1 1
Hypoxia 1 1
Pain 1 1
Complaint, Ill-Defined 1 1
Foreign Body In Patient 1 1
Partial thickness (Second Degree) Burn 1 1

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