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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dc-defibrillator, low-energy, (including paddles)
Regulation Description DC-defibrillator (including paddles).
Product CodeLDD
Regulation Number 870.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS CARDIOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 2
FIAB S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 6
KATECHO, INC.
  1
  SUBSTANTIALLY EQUIVALENT 3
MARQUETTE
  1
  SUBSTANTIALLY EQUIVALENT 6
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL RESEARCH LAB., INC.
  1
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  3
  SUBSTANTIALLY EQUIVALENT 5
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 16
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SURVIVALINK CORP.
  1
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  1
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
Failure to run on AC/DC 862
Device inoperable 460
Failure to power-up 446
Failure to deliver energy 418
Device displays error message 332
Failure to charge 250
Loss of power 121
Detachment of device component 58
Output energy incorrect 55
No display or display failure 44
Device damaged prior to use 40
Component(s), broken 36
Device Issue 35
Blank screen 25
Incorrect display 25
Connection issue 24
Failure to discharge 23
Battery charger, defective 23
Delayed charge time 19
Failure to shock or properly shock 17
Failure to sense 15
Device operates differently than expected 13
Device sensing issue 11
Component missing 11
Inappropriate shock 9
Smoking 9
EKG/ECG analysis, failure to perform 8
Power source issue 8
Loose or intermittent connection 7
Fitting problem 6
Break 6
Burn of device or device component 6
Connection error 5
Failure to analyze rhythm 5
Out-of-box failure 5
Difficult or delayed activation 5
Low battery 4
Detachment of device or device component 4
Device emits odor 4
Loose 4
Failure to pace or properly pace 4
Fire 4
Displacement 3
Alarm, no lead 3
Component falling 3
Use of Device Issue 3
Aborted charge 3
Charging issue 3
Failure to calibrate 3
Cable, defective 2
Intermittent shock 2
No voice prompts 2
Alarm system, failure of message-leads off 2
Incorrect interpretation of rhythm 2
Material separation 2
Calibration error 2
Battery failure 2
Artifact 2
Electrode contact(s), problem with 2
Contamination during use 2
Intermittent continuity 2
Failure to deliver countershock 1
Difficult to deploy 1
Unintended energization 1
Shock, electrical 1
Electrode(s), failure of 1
Energy output to patient tissue incorrect 1
Energy spectrum incorrect 1
Foreign material 1
Material fragmentation 1
Insulation failure 1
Alarm, audible 1
Device alarm system issue 1
Cable break 1
Premature discharge of battery 1
Circuit Failure 1
Colony forming units 1
Shock, failure to advise 1
Failure to recalibrate 1
Difficult to position 1
Failure, intermittent 1
Melted 1
Migration of device or device component 1
Monitor failure 1
Loss of threshold 1
Undersensing 1
Inaccurate synchronization 1
Shoulder rest, detachment of 1
Failure to select signal 1
Inaudible voice prompts 1
Noise 1
Arcing at electrodes 1
Arcing 1
Communication or transmission issue 1
Component or accessory incompatibility 1
Computer operating system issue 1
High Readings 1
Miscalibration 1
Failure to deliver 1
Wire(s), breakage of 1
Total Device Problems 3550

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 0 3 1 1 1 1 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardio Medical Products II Jul-08-2013
2 ConMed Corporation I Dec-04-2014
3 ConMed Corporation II Jan-12-2012
4 Physio Control, Inc. II Nov-16-2011
5 Physio Control, Inc. II Aug-28-2010
6 Physio Control, Inc. II Apr-07-2009
7 Physio Control, Inc. II Sep-16-2008
8 Physio Control, Inc. II Sep-16-2008
9 Physio Control, Inc. II Sep-08-2008

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