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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
Regulation Description Radiofrequency physiological signal transmitter and receiver.
Product CodeDRG
Regulation Number 870.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS
  SUBSTANTIALLY EQUIVALENT 1
ENTRA HEALTH SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
HEALTHINTERLINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
HMICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
HONEYWELL HOMMED
  SUBSTANTIALLY EQUIVALENT 1
HONEYWELL HOMMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
MEDICOMP
  SUBSTANTIALLY EQUIVALENT 1
MEDICOMP INC
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
SANITAS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL CONNECT INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL CONNECT, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Thermal Decomposition of Device 248
Failure to Power Up 160
Device Operates Differently Than Expected 93
Adverse Event Without Identified Device or Use Problem 90
Communication or Transmission Problem 61
Device Inoperable 51
Power Conditioning Problem 45
Charred 34
Overheating of Device 18
Temperature Problem 15
Radio Signal Problem 14
Loss of Power 14
Wireless Communication Problem 14
Device Component Or Accessory 14
Power Supply 14
No Display / Image 10
Break 8
Device Issue 7
Melted 7
Device Operational Issue 7
Failure to Fire 7
Device Stops Intermittently 7
Sparking 6
Smoking 6
Adapter (Adaptor) 6
Appropriate Term/Code Not Available 5
Radiofrequency Interference (RFI) 5
Device Displays Incorrect Message 4
Device Emits Odor 4
Power Cord 3
Burst Container or Vessel 3
Power Problem 3
Battery Problem 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3
Device Sensing Problem 3
Battery 2
Fire 2
Cable 2
Unintended Electrical Shock 2
Electrical /Electronic Property Problem 2
Invalid Sensing 2
Improper Alarm 2
Incorrect Interpretation of signal 2
Telemetry Discrepancy 2
Output Problem 2
Device Alarm System 2
Moisture Damage 1
Device Markings / Labelling Problem 1
Complete Loss of power 1
Incorrect, Inadequate or Imprecise Result or Readings 1
Alarm Not Visible 1
Image Display Error / Artifact 1
Electrical Shorting 1
High Readings 1
Intermittent Continuity 1
Device Difficult to Maintain 1
Incorrect Measurement 1
Application Program Version or Upgrade Problem 1
Application Security Problem 1
Operating System Becomes Nonfunctional 1
Telemetry Equipment 1
Antenna 1
False Alarm 1
Failure to Capture 1
Failure To Service 1
Inappropriate Shock 1
Failure to Read Input Signal 1
Material Integrity Problem 1
Material Discolored 1
Charging Problem 1
Total Device Problems 1038

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Sep-13-2017
2 Philips Visicu II Apr-04-2017
3 Philips Visicu II Apr-22-2016

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