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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 9
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
VITASYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Premature discharge of battery 649
Undersensing 359
Oversensing 245
Artifact 184
Device remains activated 174
No code available 122
Invalid sensing 84
Failure to interrogate 80
Device sensing issue 76
Data Issue 68
No Known Device Problem 66
Communication or transmission issue 61
Migration of device or device component 53
Device alarm system issue 49
Device operates differently than expected 44
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
Incorrect measurement 20
False positive result 16
Not audible alarm 16
No device output 16
Overheating of device or device component 16
Component missing 15
No display or display failure 15
Electro-magnetic interference (EMI) 15
Device inoperable 14
Defective item 14
Battery issue 12
No voice prompts 12
Shock, electrical 9
Electrical issue 9
Device expiration issue 8
Premature elective replacement indicator 8
Unable to obtain readings 8
Device stops intermittently 7
Telemetry discrepancy 7
Difficult to interrogate 7
Incorrect display 6
Break 6
Loss of power 6
No telemetry 6
Computer operating system issue 6
Positioning Issue 6
Reset issue 6
Output issue 5
Connection issue 5
Low battery 5
Patient-device incompatibility 4
Battery impedance issue 4
Electrode contact(s), problem with 4
Computer software issue 3
Material discolored 3
Corrosion 3
Difficult to position 3
Failure to analyze rhythm 3
Use of Device Issue 3
Shelf life exceeded 3
Power source issue 3
Protective measure issue 2
Therapeutic or diagnostic output failure 2
Inappropriate or unexpected reset 2
Dislodged or dislocated 2
Human-Device Interface Issue 2
Inaudible voice prompts 2
Algorithms, inconsistent 2
Incomplete or missing packaging 2
Product quality issue 2
Failure to pace or properly pace 2
Failure to capture 2
Disconnection 2
Intermittent continuity 2
Electrode(s), failure of 2
Mechanical issue 2
Loose or intermittent connection 2
Device maintenance issue 2
Melted 1
Lead(s), burn(s) from 1
False reading from device non-compliance 1
Use of Incorrect Control Settings 1
Display misread 1
Component falling 1
Application interface becomes non-functional or program exits abnormally 1
Pocket stimulation 1
Mislabeled 1
Device emits odor 1
Radio signal problem 1
Difficult to Program or Calibrate 1
Self-activation or keying 1
Sensing intermittently 1
Dissatisfaction 1
Failure to read input signal 1
Vibration 1
Other (for use when an appropriate device code cannot be identified) 1
Impedance issue 1
High battery impedance 1
Total Device Problems 2910

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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