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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 5
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 5
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 5930
Mechanical Problem 3581
Device Operates Differently Than Expected 2850
Battery Problem 2741
Failure to Calibrate 2594
Failure to Charge 2567
No Display/Image 2444
Device Operational Issue 2335
Circuit Failure 2314
Device Inoperable 2157
Incorrect Or Inadequate Test Results 1938
Failure to Recalibrate 1595
Appropriate Term/Code Not Available 1534
Failure to Power Up 841
Output Problem 765
Power Problem 725
Protective Measures Problem 624
No Flow 533
Calibration Problem 525
Erratic or Intermittent Display 452
Electrical /Electronic Property Problem 442
Device Alarm System 407
Failure to Deliver 396
Adverse Event Without Identified Device or Use Problem 373
Display or Visual Feedback Problem 344
Charging Problem 340
Pressure Problem 313
Leak/Splash 310
Insufficient Information 300
Failure of Device to Self-Test 298
Inaccurate Delivery 295
Unexpected Shutdown 275
Application Program Problem 269
Infusion or Flow Problem 258
Contamination 233
Failure to Cycle 226
Aborted Charge 207
Improper Flow or Infusion 202
Tidal Volume Fluctuations 194
Device Stops Intermittently 184
Noise, Audible 171
Communication or Transmission Problem 168
Gas Output Problem 166
Break 160
Self-Activation or Keying 156
No Audible Alarm 154
Use of Device Problem 152
Volume Accuracy Problem 142
Decrease in Pressure 128
Loss of Power 124
No Pressure 122
Premature Discharge of Battery 120
Incorrect, Inadequate or Imprecise Resultor Readings 117
Occlusion Within Device 115
Device Sensing Problem 109
Inadequate User Interface 109
Therapeutic or Diagnostic Output Failure 91
Battery 90
Temperature Problem 85
Suction Problem 84
Defective Alarm 80
Inappropriate or Unexpected Reset 80
Smoking 78
Disconnection 78
Computer Software Problem 75
Thermal Decomposition of Device 74
Increase in Pressure 74
Complete Loss of Power 67
Reset Problem 61
Low Readings 58
Overheating of Device 51
Screen 50
Connection Problem 46
Detachment of Device or Device Component 46
Image Display Error/Artifact 42
Gas Leak 41
High Readings 37
Crack 36
Failure To Run On AC/DC 36
Improper Alarm 33
Detachment Of Device Component 32
Defective Component 31
Unintended Collision 29
Excess Flow or Over-Infusion 29
Failure to Run on Battery 28
Obstruction of Flow 28
False Alarm 28
Ventilation Problem in Device Environment 28
Fire 27
Data Problem 26
Unexpected Therapeutic Results 24
Device Maintenance Issue 24
Moisture Damage 23
Air Leak 23
Sensor 23
Mechanical Jam 23
Application Interface Becomes Non-Functional Or Program Exits Abnormally 22
Alarm Not Visible 21
Valve(s) 20
Contamination /Decontamination Problem 20
Total Device Problems 49126

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 Philips Respironics, Inc. I Feb-15-2020
33 ResMed Ltd. II Jun-10-2015
34 Resmed Corporation II Feb-03-2016
35 Spacelabs Healthcare, Ltd. I Aug-10-2018
36 Vyaire Medical II Mar-04-2020
37 ZOLL Medical Corporation II Mar-01-2018

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