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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device oximeter
Regulation Description Oximeter.
Product CodeDQA
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 7
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 1
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 21
BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
CONMED
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 4
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 7
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 9
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
HEALTH HERO NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 7
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMAGYN MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 2
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 4
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 66
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL RESEARCH LAB., INC.
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 21
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 6
NONIN
  SUBSTANTIALLY EQUIVALENT 37
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 8
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
PALCO LABS, INC
  SUBSTANTIALLY EQUIVALENT 4
PHD MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 15
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QRS
  SUBSTANTIALLY EQUIVALENT 1
QUANTA COMPUTER INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 6
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 3
Sharp Corporation
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CREATIVE INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 6
SMITHS
  SUBSTANTIALLY EQUIVALENT 5
SOMANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
UNIMED
  SUBSTANTIALLY EQUIVALENT 2
VENTREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Incorrect measurement 969
Incorrect display 427
Device operates differently than expected 255
Failure to run on AC/DC 147
Device stops intermittently 133
Low readings 86
Patient-device incompatibility 67
Device sensing issue 60
Power source issue 54
No display or display failure 52
Device alarm system issue 48
Battery issue 48
Not audible alarm 44
No Known Device Problem 36
Component missing 31
Incorrect or inadequate result 31
Device displays error message 23
Sensing intermittently 22
Premature discharge of battery 21
Unable to obtain readings 20
No device output 15
Image display error 15
Charging issue 15
Erratic display 14
Burn of device or device component 12
Failure to charge 12
High Readings 12
Temperature issue 12
Failure to run on portable mode 11
Noise, Audible 10
Low battery 10
No code available 9
Invalid sensing 9
Loss of power 8
Failure to power-up 8
Detachment of device component 8
Defective Alarm 8
Inappropriate or unexpected reset 8
Inappropriate shock 7
Loose or intermittent connection 6
Low audible alarm 6
False alarm 5
Drift 5
Incorrect or inadequate test results 5
Device inoperable 4
Improper or incorrect procedure or method 4
Nonstandard device or device component 4
Overheating of device or device component 4
Failure to sense 4
Human-Device Interface Issue 4
Reset issue 4
Computer operating system issue 4
No Information 4
Packaging issue 3
Issue with displayed error message 3
Material integrity issue 3
Difficult to Program or Calibrate 3
Electro-static discharge 3
Malfunction 3
Artifact 3
Image orientation incorrect 3
False reading from device non-compliance 3
Break 3
Charred 2
Component(s), broken 2
Failure to Adhere or Bond 2
False device output 2
Computer software issue 2
Out-of-box failure 2
Unknown (for use when the device problem is not known) 2
Defective component 2
Use of Device Issue 2
Smoking 2
Melted 2
Material separation 2
Improper alarm 2
Improper device output 2
Component or accessory incompatibility 2
Defective item 2
Spark 2
Buckled material 2
Communication or transmission issue 1
Connection issue 1
Device markings issue 1
Dislodged or dislocated 1
Failure of device to self-test 1
Failure to shut off 1
Incompatibility problem 1
No fail-safe mechanism 1
Material deformation 1
Material Distortion 1
Scratched material 1
Programming issue 1
Operating system becomes non-functional 1
Output below specifications 1
Output issue 1
Therapeutic or diagnostic output failure 1
Data Issue 1
Device handling issue 1
Difficult to remove 1
Total Device Problems 2925

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 2 5 1 5 2 0 1 3 2 0
Class III 1 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Jul-27-2015
2 Dixtal Medical, Inc. II Dec-09-2010
3 Dixtal Medical, Inc. II Jun-28-2009
4 General Electric Medical Systems Information Technology II Jan-13-2010
5 International Technidyne Corp. II May-19-2011
6 International Technidyne Corp. II Aug-06-2008
7 Kentec Medical Inc II Jun-26-2008
8 Masimo Corporation II Nov-25-2015
9 Masimo Corporation II Nov-13-2014
10 Masimo Corporation II Apr-29-2013
11 Masimo Corporation II Feb-22-2011
12 Medtronic, Inc. II Oct-31-2007
13 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-15-2010
14 Nonin Medical, Inc II Dec-31-2014
15 Nonin Medical, Inc II Apr-11-2008
16 Oridion Capnography Inc II Nov-28-2007
17 Philips Healthcare Inc. II Apr-08-2010
18 Philips Medical Systems II Oct-10-2008
19 Philips Medical Systems III Sep-18-2008
20 Smiths Medical PM, Inc. II Mar-02-2010
21 Smiths Medical PM, Inc. II Aug-15-2008
22 Smiths Medical PM, Inc. III Sep-21-2007
23 Spacelabs Healthcare Inc II Jun-18-2014

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