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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 92
Device operates differently than expected 74
Use of Device Issue 58
Device displays error message 55
Low readings 50
Disconnection 34
Pressure sensor failure 32
High Readings 30
No Known Device Problem 30
Leak 29
Artifact 22
Unable to obtain readings 19
Incorrect or inadequate result 17
No code available 17
Incorrect measurement 16
Device handling issue 15
Device sensing issue 14
Failure to zero 14
Failure to power-up 12
No display or display failure 12
Device inoperable 12
Crack 11
Incorrect display 10
False reading from device non-compliance 9
Connection issue 9
Defective item 8
Improper device output 8
No Information 7
Electrical issue 7
Occlusion within device 7
No device output 6
Increase in pressure 6
Migration of device or device component 6
Loss of power 6
Erratic display 6
Output issue 6
Pressure issue 6
Defective component 6
Device Issue 5
Battery issue 5
Incorrect or inadequate test results 5
Fracture 5
Image display error 5
Device stops intermittently 5
Improper or incorrect procedure or method 5
Failure to sense 5
Product quality issue 4
Grounding malfunction 4
Loose or intermittent connection 4
Fluid leak 4
Out-of-box failure 4
Temperature issue 4
Power source issue 3
Patient Data Issue 3
Mechanical jam 3
Device damaged prior to use 3
Failure to advance 3
Communication or transmission issue 3
Display misread 3
Difficult to Program or Calibrate 3
Material separation 3
Difficult to remove 2
Material puncture 2
Mechanical issue 2
Material fragmentation 2
Imprecision 2
Not audible alarm 2
Material discolored 2
Bent 2
Detachment of device component 2
Device alarm system issue 2
Computer operating system issue 2
High test results 2
Low test results 2
Low battery 2
Device or device fragments location unknown 2
Charging issue 2
Improper alarm 2
Issue with displayed error message 2
Material deformation 2
Material integrity issue 2
Torn material 2
Unintended movement 2
Data Issue 2
Noise, Audible 1
Material twisted 1
Device packaging compromised 1
No flow 1
Inappropriate or unexpected reset 1
Sediment, precipitate or deposit in device or device ingredient 1
Packaging issue 1
Calibration issue 1
Detachment of device or device component 1
Dislodged or dislocated 1
Electronic property issue 1
Escape 1
Failure to unwrap 1
Foreign material present in device 1
Increased sensitivity 1
Total Device Problems 1106

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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