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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 4
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 7
MORTARA
  SUBSTANTIALLY EQUIVALENT 3
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 18
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 5
SCOTTCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 234
Device remains activated 174
Oversensing 170
Artifact 169
No code available 118
Invalid sensing 76
Device sensing issue 65
Data Issue 64
No Known Device Problem 55
Communication or transmission issue 48
Failure to sense 40
No Information 31
Burn of device or device component 26
Failure to interrogate 25
Inappropriate shock 23
Component(s), overheating of 20
Failure to power-up 19
Incorrect measurement 18
Overheating of device or device component 15
Defective item 14
Electro-magnetic interference (EMI) 14
Device alarm system issue 13
Premature discharge of battery 11
Migration of device or device component 10
Shock, electrical 9
Electrical issue 9
Device inoperable 9
Premature elective replacement indicator 8
Telemetry discrepancy 7
Difficult to interrogate 7
Device expiration issue 7
No display or display failure 6
Device displays error message 6
No telemetry 6
Low battery 5
Incorrect display 5
Device operates differently than expected 5
Electrode contact(s), problem with 4
Corrosion 3
Material discolored 3
Computer software issue 3
Use of Device Issue 3
Patient-device incompatibility 3
Shelf life exceeded 3
Difficult to position 3
Loss of power 3
Failure to analyze rhythm 3
Computer operating system issue 3
Power source issue 3
Therapeutic or diagnostic output failure 2
Battery issue 2
Human-Device Interface Issue 2
Product quality issue 2
Algorithms, inconsistent 2
Incomplete or missing packaging 2
Intermittent continuity 2
Failure to capture 2
Electrode(s), failure of 2
Failure to pace or properly pace 2
Loose or intermittent connection 2
Device maintenance issue 1
Mechanical issue 1
Melted 1
Pocket stimulation 1
Mislabeled 1
Device emits odor 1
Lead(s), burn(s) from 1
False positive result 1
Display misread 1
Use of Incorrect Control Settings 1
Not audible alarm 1
Dissatisfaction 1
Vibration 1
Other (for use when an appropriate device code cannot be identified) 1
Application network issue 1
Application program issue 1
Failure to fire 1
Malposition of device 1
Unable to obtain readings 1
Failure to read input signal 1
Device stops intermittently 1
Self-activation or keying 1
Sensing intermittently 1
Difficult to Program or Calibrate 1
Impedance issue 1
Connection issue 1
Loss of Data 1
No pacing 1
Reset issue 1
Output issue 1
Total Device Problems 1630

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 6 4 3 2 4 0
Class III 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 Philips Healthcare Inc. II Sep-29-2010
9 Philips Medical Systems II Jan-13-2009
10 Philips Medical Systems North America Co. Phillips II Oct-08-2010
11 Scottcare Corporation II Apr-13-2012
12 Spacelabs Healthcare, Incorporated II Sep-25-2008
13 Spacelabs Healthcare, Incorporated II Sep-20-2008
14 Spacelabs Healthcare, Incorporated II Sep-19-2008
15 Spacelabs Healthcare, Incorporated II Sep-18-2008
16 Spacelabs Healthcare, Incorporated II Feb-27-2007
17 Spacelabs Healthcare, Llc II Sep-14-2012
18 Spacelabs Healthcare, Llc II Jan-17-2012
19 Spacelabs Healthcare, Llc II Jan-11-2012
20 Welch Allyn Protocol, Inc II Aug-03-2011
21 Welch Allyn Protocol, Inc II Nov-12-2010

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