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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 2
COVIDIEN LP
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 4
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 4
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 3
RESMED
  SUBSTANTIALLY EQUIVALENT 2
RESMED CORP.
  SUBSTANTIALLY EQUIVALENT 2
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 5926
Device Operates Differently Than Expected 2850
Battery Problem 2404
Device Operational Issue 2335
Failure to Charge 2303
Mechanical Problem 2292
No Display / Image 2249
Device Inoperable 2157
Failure to Calibrate 2095
Incorrect Or Inadequate Test Results 1938
Circuit Failure 1653
Appropriate Term/Code Not Available 1531
Failure to Recalibrate 1118
Failure to Power Up 716
Power Problem 600
Output Problem 527
Calibration Problem 460
Erratic or Intermittent Display 442
No Flow 436
Device Alarm System 403
Protective Measures Problem 355
Adverse Event Without Identified Device or Use Problem 354
Charging Problem 335
Electrical /Electronic Property Problem 305
Leak / Splash 280
Inaccurate Delivery 278
Failure to Deliver 274
Pressure Problem 247
Display or Visual Feedback Problem 247
Insufficient Information 220
Failure to Cycle 218
Application Program Problem 210
Aborted Charge 206
Failure of Device to Self-Test 198
Device Stops Intermittently 184
Tidal Volume Fluctuations 163
Infusion or Flow Problem 163
Contamination During Use 162
Unexpected Shutdown 161
Noise, Audible 160
Self-Activation or Keying 156
Improper Flow or Infusion 154
No Audible Alarm 150
Break 149
Communication or Transmission Problem 130
Volume Accuracy Problem 129
Loss of Power 123
Occlusion Within Device 115
Device Sensing Problem 105
No Pressure 101
Incorrect, Inadequate or Imprecise Result or Readings 99
Use of Device Problem 98
Battery 90
Suction Problem 84
Defective Alarm 80
Disconnection 76
Inappropriate or Unexpected Reset 74
Premature Discharge of Battery 72
Increase in Pressure 71
Thermal Decomposition of Device 70
Temperature Problem 61
Computer Software Problem 60
Decrease in Pressure 57
Therapeutic or Diagnostic Output Failure 53
Smoking 51
Screen 50
Low Readings 49
Overheating of Device 45
Connection Problem 44
Image Display Error / Artifact 42
Gas output problem 40
Inadequate User Interface 39
Failure To Run On AC/DC 36
Crack 36
Gas Leak 34
Improper Alarm 33
Detachment Of Device Component 32
Complete Loss of power 31
Reset Problem 29
Detachment of Device or device Component 29
False Alarm 28
Ventilation Problem in Device Environment 28
High Readings 28
Excess Flow or Over-Infusion 28
Defective Component 27
Fire 25
Device Maintenance Issue 24
Unintended Collision 24
Air Leak 23
Mechanical Jam 23
Unexpected Therapeutic Results 22
Application Interface Becomes Non-Functional Or Program Exits Abnormally 22
Sensor 22
Obstruction of Flow 20
Alarm Not Visible 20
Valve 20
Material Deformation 20
Calibration Error 19
Alarm, Audible 19
Human-Device Interface Problem 19
Total Device Problems 42593

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

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