• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 651
Undersensing 360
Oversensing 247
Artifact 185
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
No display or display failure 17
Not audible alarm 16
False positive result 16
No device output 16
Overheating of device or device component 16
Component missing 15
Electro-magnetic interference (EMI) 15
Device inoperable 14
Defective item 14
No voice prompts 12
Battery issue 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
Break 6
Incorrect display 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
Material discolored 3
Corrosion 3
Computer software issue 3
Difficult to position 3
Failure to analyze rhythm 3
Shelf life exceeded 3
Use of Device Issue 3
Power source issue 3
Protective measure issue 2
Therapeutic or diagnostic output failure 2
Dislodged or dislocated 2
Human-Device Interface Issue 2
Inappropriate or unexpected reset 2
Inaudible voice prompts 2
Algorithms, inconsistent 2
Incomplete or missing packaging 2
Product quality issue 2
Failure to pace or properly pace 2
Intermittent continuity 2
Failure to capture 2
Disconnection 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
Display misread 1
Component falling 1
Application interface becomes non-functional or program exits abnormally 1
Use of Incorrect Control Settings 1
Pocket stimulation 1
Mislabeled 1
Moisture damage 1
Device emits odor 1
Output energy incorrect 1
Self-activation or keying 1
Sensing intermittently 1
Difficult to Program or Calibrate 1
Radio signal problem 1
Failure to read input signal 1
Dissatisfaction 1
Vibration 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 2918

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 3
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 Aug-04-2016
15 Spacelabs Healthcare Inc II May-04-2015
16 Spacelabs Healthcare Inc II Apr-28-2015
17 Spacelabs Healthcare Inc II Jun-03-2014
18 Spacelabs Healthcare, Incorporated II Sep-25-2008
19 Spacelabs Healthcare, Incorporated II Sep-20-2008
20 Spacelabs Healthcare, Incorporated II Sep-19-2008
21 Spacelabs Healthcare, Incorporated II Sep-18-2008
22 Spacelabs Healthcare, Incorporated II Feb-27-2007
23 Spacelabs Healthcare, Llc II Sep-14-2012
24 Spacelabs Healthcare, Llc II Jan-17-2012
25 Spacelabs Healthcare, Llc II Jan-11-2012
26 Welch Allyn Protocol, Inc II Aug-03-2011
27 Welch Allyn Protocol, Inc II Nov-12-2010

-
-