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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device detector and alarm, arrhythmia
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Product CodeDSI
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 10
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
BRAEMAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 4
CARDIONET, INC.
  SUBSTANTIALLY EQUIVALENT 6
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 3
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ELA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 19
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 12
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 17
INVIVO
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 11
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 3
MEDICALGORITHMICS SP Z.O.O.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 8
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 8
MORTARA
  SUBSTANTIALLY EQUIVALENT 3
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 18
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 12
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 5
SCOTTCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 27
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 15
SUZUKEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Undersensing 250
Premature discharge of battery 235
Oversensing 182
Device remains activated 174
Artifact 171
No code available 119
Invalid sensing 79
Failure to interrogate 72
Device sensing issue 66
Data Issue 65
No Known Device Problem 60
Communication or transmission issue 59
Device alarm system issue 49
Device operates differently than expected 43
Failure to sense 40
No Information 35
Device displays error message 31
Failure to power-up 30
Burn of device or device component 26
Inappropriate shock 23
Component(s), overheating of 20
Migration of device or device component 20
Incorrect measurement 18
Not audible alarm 16
No device output 16
Overheating of device or device component 16
Component missing 15
No display or display failure 15
Device inoperable 14
Defective item 14
Electro-magnetic interference (EMI) 14
No voice prompts 12
False positive result 11
Electrical issue 9
Shock, electrical 9
Premature elective replacement indicator 8
Telemetry discrepancy 7
Device expiration issue 7
Device stops intermittently 7
Difficult to interrogate 7
No telemetry 6
Battery issue 6
Incorrect display 6
Computer operating system issue 6
Loss of power 6
Break 5
Low battery 5
Connection issue 5
Electrode contact(s), problem with 4
Patient-device incompatibility 4
Reset issue 4
Unable to obtain readings 3
Failure to analyze rhythm 3
Computer software issue 3
Difficult to position 3
Shelf life exceeded 3
Output issue 3
Power source issue 3
Material discolored 3
Corrosion 3
Use of Device Issue 3
Therapeutic or diagnostic output failure 2
Intermittent continuity 2
Failure to capture 2
Electrode(s), failure of 2
Product quality issue 2
Human-Device Interface Issue 2
Algorithms, inconsistent 2
Mechanical issue 2
Disconnection 2
Loose or intermittent connection 2
Failure to pace or properly pace 2
Battery impedance issue 2
Inaudible voice prompts 2
Device maintenance issue 2
Incomplete or missing packaging 2
Dissatisfaction 1
Application network issue 1
Application program issue 1
Use of Incorrect Control Settings 1
Device emits odor 1
Radio signal problem 1
Sensing intermittently 1
Impedance issue 1
Positioning Issue 1
Malposition of device 1
Component falling 1
Lead(s), burn(s) from 1
Other (for use when an appropriate device code cannot be identified) 1
Operating system becomes non-functional 1
False reading from device non-compliance 1
Vibration 1
Failure to fire 1
Failure to read input signal 1
Pocket stimulation 1
Display misread 1
Application interface becomes non-functional or program exits abnormally 1
Loss of Data 1
Material integrity issue 1
Difficult to Program or Calibrate 1
Total Device Problems 2205

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 2 6 4 3 2 4 0 1 2 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Brentwood Medical Technology Corp II Jul-14-2011
2 GE Healthcare II Jan-05-2009
3 GE Medical Systems Information Tecnology II Sep-04-2009
4 GE Medical Systems Information Tecnology II May-04-2009
5 General Electric Medical Systems Information Technology II Feb-01-2008
6 General Electric Medical Systems Information Technology II Jan-17-2008
7 General Electric Medical Systems Information Technology II Jun-06-2007
8 Medtronic Inc. II Mar-25-2016
9 Philips Healthcare Inc. II Sep-29-2010
10 Philips Medical Systems II Jan-13-2009
11 Philips Medical Systems North America Co. Phillips II Oct-08-2010
12 Scottcare Corporation II Apr-01-2016
13 Scottcare Corporation II Apr-13-2012
14 Spacelabs Healthcare Inc II May-04-2015
15 Spacelabs Healthcare Inc II Apr-28-2015
16 Spacelabs Healthcare Inc II Jun-03-2014
17 Spacelabs Healthcare, Incorporated II Sep-25-2008
18 Spacelabs Healthcare, Incorporated II Sep-20-2008
19 Spacelabs Healthcare, Incorporated II Sep-19-2008
20 Spacelabs Healthcare, Incorporated II Sep-18-2008
21 Spacelabs Healthcare, Incorporated II Feb-27-2007
22 Spacelabs Healthcare, Llc II Sep-14-2012
23 Spacelabs Healthcare, Llc II Jan-17-2012
24 Spacelabs Healthcare, Llc II Jan-11-2012
25 Welch Allyn Protocol, Inc II Aug-03-2011
26 Welch Allyn Protocol, Inc II Nov-12-2010

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