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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, monitoring, intracranial pressure
Regulation Description Intracranial pressure monitoring device.
Product CodeGWM
Regulation Number 882.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
CMA MICRODIALYSIS AB
  SUBSTANTIALLY EQUIVALENT 4
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 8
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 3
DIAMETRICS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INNERSPACE, INC.
  SUBSTANTIALLY EQUIVALENT 6
INTEGRA
  SUBSTANTIALLY EQUIVALENT 13
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
MEDEX
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
RAUMEDIC AG
  SUBSTANTIALLY EQUIVALENT 4
SOPHYSA SA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 176
Break 69
Device operates differently than expected 51
Device displays error message 46
Use of Device Issue 45
Pressure sensor failure 32
Low readings 27
Artifact 22
No Known Device Problem 21
High Readings 15
Device handling issue 15
Leak 15
Unable to obtain readings 13
Failure to power-up 11
No display or display failure 11
Disconnection 11
Crack 11
Incorrect or inadequate result 10
Device inoperable 10
Device sensing issue 9
False reading from device non-compliance 9
Incorrect display 9
Failure to zero 7
Connection issue 7
Pressure issue 6
Improper device output 6
Increase in pressure 6
Migration of device or device component 6
No device output 5
Failure to sense 5
Device Issue 5
Battery issue 5
Defective item 5
No code available 5
Temperature issue 4
No Information 4
Incorrect or inadequate test results 4
Defective component 4
Out-of-box failure 4
Loss of power 4
Loose or intermittent connection 4
Incorrect measurement 4
Fracture 4
Grounding malfunction 4
Image display error 4
Material separation 3
Difficult to Program or Calibrate 3
Improper or incorrect procedure or method 3
Device stops intermittently 3
Communication or transmission issue 3
Computer operating system issue 2
Low battery 2
Unintended movement 2
Charging issue 2
Power source issue 2
Issue with displayed error message 2
Material integrity issue 2
Data Issue 2
Difficult to remove 2
Device damaged prior to use 2
High test results 2
Low test results 2
Material puncture 2
Fluid leak 2
Occlusion within device 2
Material fragmentation 2
Mechanical issue 2
Bent 2
Detachment of device component 2
Device alarm system issue 2
Defective Alarm 1
Not audible alarm 1
Premature discharge of battery 1
Burn of device or device component 1
Failure to charge 1
Component(s), broken 1
Component falling 1
Continuous firing 1
Loss of or failure to bond 1
Application interface becomes non-functional or program exits abnormally 1
Disassembly 1
Material discolored 1
Image resolution poor 1
Electro-magnetic interference (EMI) 1
Explanted 1
Restricted flowrate 1
Display misread 1
Erratic display 1
Nonstandard device or device component 1
Overheating of device or device component 1
Difficult to position 1
Slippage of device or device component 1
Failure to calibrate 1
Tube(s), buckling of 1
Wire(s), breakage of 1
Device remains activated 1
Device, or device fragments remain in patient 1
Noise, Audible 1
Mechanical jam 1
No flow 1
Total Device Problems 835

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 0 1 0 2 2 2 3 3 2 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Integra Neuro Sciences II Aug-05-2008
2 Codman & Shurtleff, Inc. II Mar-22-2012
3 Codman & Shurtleff, Inc. II Jan-11-2012
4 Codman & Shurtleff, Inc. II Apr-20-2011
5 Integra LifeSciences Corp III Feb-03-2012
6 Integra LifeSciences Corp. II Jun-18-2015
7 Integra LifeSciences Corp. II May-15-2015
8 Integra LifeSciences Corp. II Dec-18-2014
9 Integra LifeSciences Corp. II Nov-10-2014
10 Integra LifeSciences Corp. II May-30-2014
11 Integra LifeSciences Corp. II Dec-27-2013
12 Integra LifeSciences Corp. II Oct-23-2013
13 Integra LifeSciences Corp. II Mar-03-2011
14 Integra LifeSciences Corp. II Oct-28-2010
15 Integra LifeSciences Corp. II Apr-20-2010
16 Integra Limited II Oct-30-2013

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