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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, continuous, facility use
Regulation Description Continuous ventilator.
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-MED
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN LP
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 2
HAMILTON
  SUBSTANTIALLY EQUIVALENT 4
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 4
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 3
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 3
RESMED
  SUBSTANTIALLY EQUIVALENT 3
RESMED CORP.
  SUBSTANTIALLY EQUIVALENT 3
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Displays Incorrect Message 6782
Device Operates Differently Than Expected 3016
Incorrect Or Inadequate Test Results 2516
Device Operational Issue 2342
Device Inoperable 2311
Battery Problem 2298
Failure to Charge 2280
No Display / Image 2252
Failure to Calibrate 2024
Appropriate Term/Code Not Available 1842
Mechanical Problem 1797
Circuit Failure 1341
Failure to Recalibrate 893
Failure to Power Up 853
Power Problem 601
Device Alarm System 446
Erratic or Intermittent Display 442
Output Problem 440
Calibration Problem 427
No Flow 402
Adverse Event Without Identified Device or Use Problem 370
Electrical /Electronic Property Problem 357
Charging Problem 347
Protective Measures Problem 282
Leak / Splash 279
Inaccurate Delivery 263
Failure to Deliver 255
Pressure Problem 237
Failure to Cycle 236
Display or Visual Feedback Problem 234
Aborted Charge 208
Device Stops Intermittently 186
Insufficient Information 181
Application Program Problem 179
No Audible Alarm 177
Break 175
Failure of Device to Self-Test 168
Tidal Volume Fluctuations 164
Noise, Audible 161
Self-Activation or Keying 159
Contamination During Use 155
Infusion or Flow Problem 151
Volume Accuracy Problem 147
Improper Flow or Infusion 130
Loss of Power 125
Occlusion Within Device 121
Unexpected Shutdown 118
Device Sensing Problem 107
Communication or Transmission Problem 106
Battery 90
Incorrect, Inadequate or Imprecise Result or Readings 86
Suction Problem 84
Use of Device Problem 83
Connection Problem 83
Detachment Of Device Component 81
Defective Alarm 78
Disconnection 76
Increase in Pressure 75
Thermal Decomposition of Device 71
Premature Discharge of Battery 70
Inappropriate or Unexpected Reset 65
Temperature Problem 59
Decrease in Pressure 57
Computer Software Problem 56
Screen 50
Smoking 46
Failure To Run On AC/DC 44
Overheating of Device 43
Low Readings 43
Image Display Error / Artifact 42
No Pressure 41
Crack 39
Unintended Collision 37
Improper Alarm 34
Therapeutic or Diagnostic Output Failure 33
Gas Leak 31
Excess Flow or Over-Infusion 29
Reset Problem 28
Alarm Not Visible 28
Ventilation Problem in Device Environment 28
High Readings 28
False Alarm 27
Detachment of Device or device Component 27
Valve 26
Defective Component 26
Fire 25
Device Maintenance Issue 24
Air Leak 24
Mechanical Jam 23
Calibration Error 22
Unexpected Therapeutic Results 22
Application Interface Becomes Non-Functional Or Program Exits Abnormally 22
Gas output problem 21
Device Issue 21
Material Deformation 20
Loose or Intermittent Connection 20
Material Integrity Problem 20
Human-Device Interface Problem 19
Alarm, Audible 19
Sensor 19
Total Device Problems 43248

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC I Dec-18-2018
2 CareFusion 203, Inc. I Sep-19-2014
3 Carefusion 211 Inc dba Carefusion I Jun-13-2016
4 Carefusion 211 Inc dba Carefusion I May-26-2015
5 Covidien I Jan-03-2014
6 Covidien LLC II Mar-27-2018
7 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Mar-17-2016
8 Covidien LP (formerly Nellcor Puritan Bennett Inc.) I Aug-14-2015
9 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Feb-05-2015
10 Datex-Ohmeda, Inc. II Aug-08-2018
11 Datex-Ohmeda, Inc. II Jun-01-2018
12 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
13 Del Mar Reynolds Medical, Ltd. II Apr-20-2015
14 Del Mar Reynolds Medical, Ltd. I Apr-12-2014
15 Draeger Medical Systems, Inc. I Mar-28-2014
16 Draeger Medical, Inc. II May-29-2018
17 Draeger Medical, Inc. I Aug-04-2016
18 Draeger Medical, Inc. I Feb-25-2016
19 Draeger Medical, Inc. I Feb-03-2016
20 Draeger Medical, Inc. I Dec-23-2015
21 Draeger Medical, Inc. I Aug-14-2015
22 Event Medical LTD I Nov-19-2015
23 GE Healthcare II Mar-24-2015
24 GE Healthcare, LLC I Nov-30-2018
25 GE Medical Systems, LLC II Jan-21-2016
26 Hamilton Medical AG I Jul-11-2019
27 Hamilton Medical AG II Aug-14-2018
28 Hamilton Medical AG II Apr-12-2018
29 Hamilton Medical, Inc. II Nov-28-2016
30 Hamilton Medical, Inc. II May-09-2016
31 Hamilton Medical, Inc. I Nov-04-2015
32 Hamilton Medical, Inc. II Jul-10-2015
33 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Dec-09-2014
34 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Oct-28-2014
35 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-20-2014
36 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-17-2014
37 Nellcor Puritan Bennett Inc. (dba Covidien LP) II May-09-2014
38 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jan-24-2014
39 Newport Medical Instruments Inc I Apr-10-2017
40 Newport Medical Instruments Inc I Apr-14-2014
41 Philips Respironics II Mar-07-2016
42 Phillips Respironics, Inc. I Mar-06-2014
43 ResMed Ltd. II Jun-10-2015
44 Resmed Corporation II Feb-03-2016
45 Respironics California Inc II Dec-01-2014
46 Respironics California Inc I Oct-21-2014
47 Spacelabs Healthcare, Ltd. I Aug-10-2018
48 ZOLL Medical Corporation II Mar-01-2018

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