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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
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
AFRAME DIGITAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BRAEMAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOCOM LLC
  SUBSTANTIALLY EQUIVALENT 1
CAREMATIX INC.
  SUBSTANTIALLY EQUIVALENT 3
CERNER CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONFIDANT INC.
  SUBSTANTIALLY EQUIVALENT 3
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
HEALTH HERO NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 4
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 2
HONEYWELL HOMMED, LLC
  SUBSTANTIALLY EQUIVALENT 5
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEL CORP.
  SUBSTANTIALLY EQUIVALENT 3
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
INTOUCH TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
MEDAPPS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIC4ALL (ISRAEL) LTD.
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICOMP
  SUBSTANTIALLY EQUIVALENT 2
MORTARA
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 6
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RTX HEALTHCARE A/S
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Burn of device or device component 167
Failure to power-up 103
Device operates differently than expected 89
No Known Device Problem 63
Device inoperable 50
Power Conditioning Issue 43
Charred 30
Communication or transmission issue 23
Temperature issue 14
Wireless communication issue 12
Overheating of device or device component 12
Radio signal problem 9
No display or display failure 7
Device stops intermittently 7
Failure to fire 7
Melted 5
Break 3
Application interface becomes non-functional or program exits abnormally 3
Burst 3
Battery issue 3
Device displays error message 3
Radiofrequency interference (RFI) 3
Invalid sensing 2
Inappropriate shock 2
Device sensing issue 2
Fire 2
Incorrect measurement 1
Device emits odor 1
Failure to service 1
Failure to capture 1
False alarm 1
Alarm not visible 1
Battery failure 1
Material discolored 1
Intermittent continuity 1
Electrical shorting 1
Improper alarm 1
Material integrity issue 1
Spark 1
Charging issue 1
Failure to read input signal 1
Telemetry discrepancy 1
Device Issue 1
Device markings issue 1
Output issue 1
Power source issue 1
Total Device Problems 687

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 1 0 0 0 0 2 0 0 1 2
Class III 0 0 0 0 0 0 0 0 0 0 0

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 GMP Companies/Lifesync Corporation II Feb-27-2007
5 Lifesync Corporation II Sep-16-2008
6 Philips Visicu II Apr-04-2017
7 Philips Visicu II Apr-22-2016

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