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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gas-machine, anesthesia
Regulation Description Gas machine for anesthesia or analgesia.
Product CodeBSZ
Regulation Number 868.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 4
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
THORNHILL RESEARCH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Operates Differently Than Expected 1394
Therapeutic or Diagnostic Output Failure 1142
Appropriate Term/Code Not Available 1128
Mechanical Problem 785
Device Alarm System 618
Device Displays Incorrect Message 452
Leak/Splash 405
Output Problem 395
Pressure Problem 331
Gas Leak 305
Break 288
Infusion or Flow Problem 254
Suction Problem 227
Increase in Pressure 209
Device Inoperable 209
Tidal Volume Fluctuations 164
Unexpected Therapeutic Results 161
Unexpected Shutdown 155
Failure to Deliver 152
Physical Resistance/Sticking 151
Energy Output Problem 121
Excess Flow or Over-Infusion 118
Gas Output Problem 117
Inaccurate Delivery 110
Suction Failure 109
No Display/Image 107
Mechanical Jam 107
Decrease in Suction 96
Inappropriate or Unexpected Reset 77
Sticking 67
No Pressure 67
High Readings 58
Detachment of Device or Device Component 56
Incorrect, Inadequate or Imprecise Resultor Readings 48
Battery Problem 37
No Audible Alarm 34
Intermittent Continuity 30
Crack 27
Defective Alarm 26
Computer Software Problem 23
Failure to Run on Battery 21
Loss of Power 21
Material Integrity Problem 21
Failure of Device to Self-Test 21
No Flow 21
Loose or Intermittent Connection 19
Decrease in Pressure 16
Electrical /Electronic Property Problem 16
Failure to Calibrate 16
Power Problem 15
Improper Flow or Infusion 15
Device Stops Intermittently 15
Intermittent Communication Failure 14
Air Leak 14
Device Tipped Over 12
Failure to Power Up 9
Communication or Transmission Problem 9
Reset Problem 9
Insufficient Information 9
Partial Blockage 9
Adverse Event Without Identified Device or Use Problem 9
Display or Visual Feedback Problem 8
Use of Device Problem 8
Failure to Sense 8
Data Problem 7
Device Fell 7
Computer System Security Problem 7
Calibration Problem 7
Circuit Failure 7
Alarm Not Visible 6
Connection Problem 6
Disconnection 6
Device Damaged Prior to Use 6
Failure to Analyze Signal 6
Unauthorized Access to Computer System 6
Detachment Of Device Component 6
Improper Device Output 5
Computer Operating System Problem 5
Inflation Problem 5
Moisture or Humidity Problem 5
Defective Component 5
No Device Output 5
Protective Measures Problem 5
Component Missing 4
Noise, Audible 4
Device Sensing Problem 4
Complete Loss of Power 4
Device Dislodged or Dislocated 4
Device Handling Problem 4
Premature Discharge of Battery 4
Failure To Run On AC/DC 3
Device Reprocessing Problem 3
Component Falling 3
Deflation Problem 3
Operating System Becomes Nonfunctional 3
Loss of Threshold 3
Inaccurate Flow Rate 3
Incorrect Or Inadequate Test Results 3
Valve(s) 3
Delivery System Failure 3
Total Device Problems 10865

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-30-2016
2 Del Mar Reynolds Medical, Ltd. II May-16-2017
3 Draeger Medical, Inc. II Jun-19-2018
4 Draeger Medical, Inc. I May-08-2018
5 Draeger Medical, Inc. I Dec-12-2015
6 Draeger Medical, Inc. II Jul-27-2015
7 GE Healthcare II Apr-02-2015
8 GE Healthcare, LLC I Jan-23-2020
9 GE Healthcare, LLC II Dec-17-2019
10 GE Healthcare, LLC II Nov-09-2018
11 GE Healthcare, LLC II Mar-26-2018
12 GE Healthcare, LLC II May-24-2017
13 GE Healthcare, LLC II Dec-14-2016
14 GE Medical Systems China Co., Ltd. II Aug-30-2018
15 GE Medical Systems China Co., Ltd. II Feb-09-2018
16 GE Medical Systems, LLC II Apr-22-2016
17 GE Medical Systems, LLC II Apr-13-2016
18 GE Medical Systems, LLC II Jan-21-2016
19 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
20 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
21 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
22 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
23 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
24 Spacelabs Healthcare, Ltd. I Nov-21-2017

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