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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 5
SOPHYSA SA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 176
Break 97
Device operates differently than expected 93
Use of Device Issue 58
Device displays error message 56
Low readings 53
Disconnection 36
High Readings 33
No Known Device Problem 32
Leak 32
Pressure sensor failure 32
Artifact 27
Incorrect display 21
Incorrect or inadequate result 21
Unable to obtain readings 19
No code available 18
Incorrect measurement 17
Device handling issue 16
Device sensing issue 14
Failure to zero 14
Failure to power-up 14
Electrical issue 13
No display or display failure 13
Device inoperable 12
Crack 11
Connection issue 11
No Information 11
Improper device output 9
False reading from device non-compliance 9
Output issue 8
Defective item 8
Occlusion within device 7
No device output 7
Loss of power 6
Migration of device or device component 6
Increase in pressure 6
Erratic display 6
Defective component 6
Pressure issue 6
Improper or incorrect procedure or method 5
Device Issue 5
Incorrect or inadequate test results 5
Battery issue 5
Fracture 5
Image display error 5
Device stops intermittently 5
Failure to sense 5
Product quality issue 4
Loose or intermittent connection 4
Fluid leak 4
Grounding malfunction 4
Communication or transmission issue 4
Out-of-box failure 4
Temperature issue 4
Power source issue 4
Mechanical jam 4
Issue with displayed error message 3
Patient Data Issue 3
Device or device fragments location unknown 3
Device damaged prior to use 3
Failure to advance 3
Display misread 3
Material discolored 3
Material separation 3
Difficult to Program or Calibrate 3
Material puncture 2
Difficult to remove 2
Imprecision 2
Mechanical issue 2
Not audible alarm 2
Bent 2
Detachment of device component 2
Device alarm system issue 2
Material fragmentation 2
Computer operating system issue 2
Low battery 2
Charging issue 2
High test results 2
Low test results 2
Data Issue 2
Improper alarm 2
Torn material 2
Unintended movement 2
Material deformation 2
Material integrity issue 2
Material twisted 1
No flow 1
Inappropriate or unexpected reset 1
Detachment of device or device component 1
Device packaging compromised 1
Dislodged or dislocated 1
Electronic property issue 1
Escape 1
Failure to unwrap 1
Foreign material present in device 1
Sediment, precipitate or deposit in device or device ingredient 1
Packaging issue 1
Noise, Audible 1
Failure to calibrate 1
Incomplete or missing packaging 1
Total Device Problems 1192

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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