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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 81
Device operates differently than expected 63
Use of Device Issue 55
Device displays error message 52
Low readings 47
Pressure sensor failure 32
Disconnection 28
No Known Device Problem 28
Leak 27
High Readings 26
Artifact 22
Unable to obtain readings 18
No code available 17
Device handling issue 15
Device sensing issue 14
Incorrect measurement 14
Incorrect or inadequate result 14
Failure to power-up 12
Device inoperable 12
Failure to zero 11
Crack 11
No display or display failure 11
Incorrect display 10
False reading from device non-compliance 9
Defective item 8
Connection issue 7
No Information 7
Improper device output 7
Electrical issue 7
Loss of power 6
Migration of device or device component 6
No device output 6
Increase in pressure 6
Pressure issue 6
Defective component 6
Device Issue 5
Incorrect or inadequate test results 5
Battery issue 5
Failure to sense 5
Improper or incorrect procedure or method 5
Device stops intermittently 5
Image display error 5
Fluid leak 4
Fracture 4
Loose or intermittent connection 4
Grounding malfunction 4
Occlusion within device 4
Out-of-box failure 4
Temperature issue 4
Output issue 4
Power source issue 3
Patient Data Issue 3
Device damaged prior to use 3
Failure to advance 3
Communication or transmission issue 3
Difficult to Program or Calibrate 3
Material separation 3
Product quality issue 3
Display misread 3
Imprecision 2
Material fragmentation 2
Not audible alarm 2
Material discolored 2
Bent 2
Detachment of device component 2
Device alarm system issue 2
Difficult to remove 2
Material puncture 2
Mechanical issue 2
Computer operating system issue 2
Issue with displayed error message 2
Material deformation 2
Material integrity issue 2
Low battery 2
High test results 2
Low test results 2
Data Issue 2
Torn material 2
Unintended movement 2
Charging issue 2
Mechanical jam 2
No flow 1
Inappropriate or unexpected reset 1
Packaging issue 1
Sediment, precipitate or deposit in device or device ingredient 1
Noise, Audible 1
Increased sensitivity 1
Incomplete or missing packaging 1
Tube(s), buckling of 1
Wire(s), breakage of 1
Failure to calibrate 1
Component missing 1
Material twisted 1
Dislodged or dislocated 1
Electronic property issue 1
Escape 1
Failure to unwrap 1
Foreign material present in device 1
Improper alarm 1
Total Device Problems 1033

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