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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
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 11
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 2401
Undersensing 1526
Oversensing 888
Migration of device or device component 317
Artifact 218
Invalid sensing 211
Failure to interrogate 187
Device remains activated 174
No code available 154
No Known Device Problem 131
Device sensing issue 112
Unable to obtain readings 107
Communication or transmission issue 82
Data Issue 70
Device operates differently than expected 65
Device alarm system issue 48
Incorrect measurement 45
Reset issue 41
Failure to sense 40
Battery issue 38
Decreased sensitivity 37
No Information 36
Device displays error message 31
Failure to power-up 31
Burn of device or device component 26
Inappropriate shock 23
Positioning Issue 23
Component(s), overheating of 20
No display or display failure 20
False positive result 17
No device output 17
Overheating of device or device component 16
Not audible alarm 16
Electro-magnetic interference (EMI) 15
Component missing 15
Defective item 14
Electrical issue 13
Device inoperable 13
No voice prompts 12
Device expiration issue 12
Battery impedance issue 10
Inappropriate or unexpected reset 10
Shock, electrical 9
Premature elective replacement indicator 8
Output issue 8
Difficult to interrogate 7
Device stops intermittently 7
Telemetry discrepancy 7
Break 7
Incorrect display 6
Use of Device Issue 6
Loss of power 6
Computer operating system issue 6
No telemetry 6
Connection issue 5
Low battery 5
Patient-device incompatibility 4
Electrode contact(s), problem with 4
Loose or intermittent connection 3
Computer software issue 3
Corrosion 3
Material discolored 3
Difficult to position 3
Shelf life exceeded 3
Failure to analyze rhythm 3
Dislodged or dislocated 3
Power source issue 3
Protective measure issue 3
Therapeutic or diagnostic output failure 2
Human-Device Interface Issue 2
Manufacturing or shipping issue associated with device 2
Material integrity issue 2
Incomplete or missing packaging 2
Inaudible voice prompts 2
Algorithms, inconsistent 2
Difficult to Program or Calibrate 2
Product quality issue 2
Failure to pace or properly pace 2
Disconnection 2
Intermittent continuity 2
Failure to capture 2
Device maintenance issue 2
Mechanical issue 2
Electrode(s), failure of 2
Melted 1
False reading from device non-compliance 1
Lead(s), burn(s) from 1
Circuit Failure 1
Bent 1
Use of Incorrect Control Settings 1
Display misread 1
Application interface becomes non-functional or program exits abnormally 1
Pocket stimulation 1
Mislabeled 1
Moisture damage 1
Device emits odor 1
Output energy incorrect 1
Radio signal problem 1
Vibration 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 7461

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 1
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 Electronics North America Corporation II Apr-04-2017
10 Philips Healthcare Inc. II Sep-29-2010
11 Philips Medical Systems II Jan-13-2009
12 Philips Medical Systems North America Co. Phillips II Oct-08-2010
13 Scottcare Corporation II Apr-01-2016
14 Scottcare Corporation II Apr-13-2012
15 Spacelabs Healthcare Inc II Aug-04-2016
16 Spacelabs Healthcare Inc II May-04-2015
17 Spacelabs Healthcare Inc II Apr-28-2015
18 Spacelabs Healthcare Inc II Jun-03-2014
19 Spacelabs Healthcare, Incorporated II Sep-25-2008
20 Spacelabs Healthcare, Incorporated II Sep-20-2008
21 Spacelabs Healthcare, Incorporated II Sep-19-2008
22 Spacelabs Healthcare, Incorporated II Sep-18-2008
23 Spacelabs Healthcare, Incorporated II Feb-27-2007
24 Spacelabs Healthcare, Llc II Sep-14-2012
25 Spacelabs Healthcare, Llc II Jan-17-2012
26 Spacelabs Healthcare, Llc II Jan-11-2012
27 Welch Allyn Protocol, Inc II Aug-03-2011
28 Welch Allyn Protocol, Inc II Nov-12-2010

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