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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 78
Device operates differently than expected 57
Use of Device Issue 52
Device displays error message 49
Low readings 37
Pressure sensor failure 32
No Known Device Problem 23
Artifact 22
Disconnection 20
Leak 20
High Readings 19
Unable to obtain readings 16
Device handling issue 15
Device sensing issue 14
No code available 13
Incorrect measurement 12
Incorrect or inadequate result 12
Failure to power-up 11
No display or display failure 11
Crack 11
Incorrect display 10
Failure to zero 10
Device inoperable 10
False reading from device non-compliance 9
Connection issue 7
Improper device output 7
Defective item 6
Defective component 6
Pressure issue 6
Migration of device or device component 6
Increase in pressure 6
No device output 5
Failure to sense 5
Image display error 5
No Information 5
Device Issue 5
Battery issue 5
Incorrect or inadequate test results 4
Out-of-box failure 4
Output issue 4
Temperature issue 4
Loose or intermittent connection 4
Fracture 4
Loss of power 4
Device stops intermittently 4
Grounding malfunction 4
Occlusion within device 3
Difficult to Program or Calibrate 3
Material separation 3
Improper or incorrect procedure or method 3
Failure to advance 3
Communication or transmission issue 3
Computer operating system issue 2
Issue with displayed error message 2
Material deformation 2
Material integrity issue 2
Mechanical jam 2
Low battery 2
Charging issue 2
High test results 2
Low test results 2
Power source issue 2
Unintended movement 2
Data Issue 2
Patient Data Issue 2
Device damaged prior to use 2
Difficult to remove 2
Material puncture 2
Mechanical issue 2
Material fragmentation 2
Material discolored 2
Fluid leak 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
Display misread 1
Erratic display 1
Restricted flowrate 1
Electro-magnetic interference (EMI) 1
Electrical issue 1
Explanted 1
Image resolution poor 1
Imprecision 1
Excess flow or overinfusion 1
Nonstandard device or device component 1
Overheating of device or device component 1
Difficult to position 1
Failure to recalibrate 1
Total Device Problems 937

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 1
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
17 Spiegelberg Gmbh & Co. KG II Sep-26-2016

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