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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
MEDICOMP
  SUBSTANTIALLY EQUIVALENT 6
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 1679
Undersensing 720
Oversensing 413
Artifact 217
Device remains activated 174
Migration of device or device component 169
No code available 135
Failure to interrogate 122
Invalid sensing 95
Device sensing issue 89
No Known Device Problem 86
Data Issue 69
Communication or transmission issue 68
Device alarm system issue 50
Device operates differently than expected 45
Failure to sense 40
Unable to obtain readings 39
No Information 35
Incorrect measurement 33
Device displays error message 31
Failure to power-up 30
Burn of device or device component 26
Battery issue 24
Inappropriate shock 23
Component(s), overheating of 20
No display or display failure 19
False positive result 17
No device output 17
Reset issue 17
Overheating of device or device component 16
Not audible alarm 16
Component missing 15
Electro-magnetic interference (EMI) 15
Defective item 14
Device inoperable 14
Positioning Issue 13
No voice prompts 12
Device expiration issue 10
Electrical issue 10
Shock, electrical 9
Premature elective replacement indicator 8
Battery impedance issue 8
Telemetry discrepancy 7
Difficult to interrogate 7
Device stops intermittently 7
No telemetry 6
Computer operating system issue 6
Loss of power 6
Output issue 6
Incorrect display 6
Break 6
Low battery 5
Connection issue 5
Inappropriate or unexpected reset 5
Electrode contact(s), problem with 4
Use of Device Issue 4
Patient-device incompatibility 4
Power source issue 3
Material discolored 3
Corrosion 3
Loose or intermittent connection 3
Computer software issue 3
Failure to analyze rhythm 3
Shelf life exceeded 3
Difficult to position 3
Protective measure issue 3
Incomplete or missing packaging 2
Device maintenance issue 2
Inaudible voice prompts 2
Algorithms, inconsistent 2
Mechanical issue 2
Disconnection 2
Failure to pace or properly pace 2
Product quality issue 2
Failure to capture 2
Electrode(s), failure of 2
Human-Device Interface Issue 2
Therapeutic or diagnostic output failure 2
Dislodged or dislocated 2
Decreased sensitivity 2
Intermittent continuity 2
Self-activation or keying 1
No pacing 1
Difficult to Program or Calibrate 1
Deployment issue 1
Melted 1
Mislabeled 1
Bent 1
Operating system becomes non-functional 1
False reading from device non-compliance 1
Output energy incorrect 1
Vibration 1
Display misread 1
Failure to fire 1
Failure to read input signal 1
Pocket stimulation 1
Loss of Data 1
Material integrity issue 1
Application interface becomes non-functional or program exits abnormally 1
Issue with displayed error message 1
Total Device Problems 4822

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 2 6 4 3 2 4 0 1 2 3 0
Class III 0 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

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