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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
CODONICS.INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRÄGERWERK AG CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K171292  A7 Anesthesia System
  2.  K171311  A5 Anesthesia System
  3.  K201957  A8, A9 Anesthesia System

MDR Year MDR Reports MDR Events
2018 2589 2590
2019 1957 2270
2020 2687 2688
2021 3123 3124
2022 4352 4355
2023 5595 5596
2024 6067 6067
2025 9366 9366
2026 2122 2122

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 6633 6828
Mechanical Problem 4294 4322
No Flow 3644 3644
Failure to Run on Battery 3629 3629
Insufficient Flow or Under Infusion 2269 2269
No Display/Image 1635 1635
Power Problem 1438 1438
Unexpected Therapeutic Results 1326 1329
Output Problem 1255 1255
Gas/Air Leak 1241 1274
Failure to Deliver 1235 1235
Electrical /Electronic Property Problem 1190 1190
Gas Output Problem 1029 1030
Increase in Pressure 928 942
Unexpected Shutdown 883 888
Infusion or Flow Problem 726 736
Inaccurate Delivery 482 484
Failure to Power Up 437 437
Appropriate Term/Code Not Available 378 378
Pressure Problem 358 362
Physical Resistance/Sticking 319 324
Leak/Splash 298 298
Suction Failure 291 295
Break 291 295
Decrease in Suction 251 260
Improper Flow or Infusion 227 227
Intermittent Continuity 224 224
Inappropriate or Unexpected Reset 217 218
Insufficient Information 215 215
Device Displays Incorrect Message 208 208
Device Alarm System 208 208
Device Operates Differently Than Expected 202 202
No Visual Prompts/Feedback 187 187
Decrease in Pressure 175 175
No Apparent Adverse Event 174 174
Detachment of Device or Device Component 171 171
Intermittent Communication Failure 162 162
No Pressure 152 152
Energy Output Problem 145 147
Complete Loss of Power 140 140
No Audible Alarm 140 141
Protective Measures Problem 112 112
Mechanical Jam 108 108
Suction Problem 103 103
Battery Problem 101 101
Adverse Event Without Identified Device or Use Problem 101 102
Excess Flow or Over-Infusion 101 101
Failure to Analyze Signal 96 96
Use of Device Problem 85 88
Degraded 79 79

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30365 30367
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1926
Insufficient Information 847 850
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 150 150
Cardiac Arrest 38 38
Hypoxia 32 32
Awareness during Anaesthesia 24 24
Hypoventilation 23 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Distress 20 20
Death 18 18
Patient Problem/Medical Problem 15 15
No Information 13 14
Burn(s) 10 10
Cyanosis 9 9
Vomiting 9 9
Nausea 9 9
Loss of consciousness 9 9
Bradycardia 7 7
Pneumothorax 6 6
Brain Injury 6 6
Capsular Contracture 5 5
Airway Obstruction 5 5
Low Blood Pressure/ Hypotension 5 5
No Code Available 5 5
Tachycardia 4 4
Oversedation 4 4
Unspecified Respiratory Problem 4 4
Dizziness 4 4
Respiratory Arrest 4 4
Therapeutic Effects, Unexpected 3 5
Emotional Changes 3 3
Respiratory Distress 3 3
Cardiopulmonary Arrest 3 3
Apnea 3 3
Low Cardiac Output 2 2
Headache 2 2
Fecal Incontinence 2 2
Convulsion/Seizure 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Respiratory Insufficiency 2 2
Chills 2 2
Urinary Retention 2 2
Partial thickness (Second Degree) Burn 2 2
Coma 2 2
Laceration(s) 2 2
Bronchospasm 2 2
Asystole 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Datex-Ohmeda, Inc. I Oct-18-2024
2 Draeger Medical, Inc. I Dec-18-2024
3 Draeger Medical, Inc. I Nov-13-2024
4 Draeger Medical, Inc. I Apr-18-2024
5 Draeger Medical, Inc. II Jan-14-2022
6 Draeger Medical, Inc. II Jun-19-2018
7 Draeger Medical, Inc. I May-08-2018
8 Draeger, Inc. I Oct-01-2025
9 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
10 GE Healthcare, LLC II Jul-20-2022
11 GE Healthcare, LLC I Jul-19-2022
12 GE Healthcare, LLC II Jun-24-2022
13 GE Healthcare, LLC II Sep-30-2021
14 GE Healthcare, LLC II Oct-30-2020
15 GE Healthcare, LLC I Jan-23-2020
16 GE Healthcare, LLC II Dec-17-2019
17 GE Healthcare, LLC II Nov-09-2018
18 GE Healthcare, LLC II Mar-26-2018
19 GE Medical Systems China Co., Ltd. I Dec-18-2025
20 GE Medical Systems China Co., Ltd. I Apr-29-2025
21 GE Medical Systems China Co., Ltd. II Aug-30-2018
22 GE Medical Systems China Co., Ltd. II Feb-09-2018
23 Getinge Group Logistics America, LLC II Mar-05-2021
24 Getinge Usa Sales Inc I Feb-07-2025
25 Getinge Usa Sales Inc I May-31-2024
26 Getinge Usa Sales Inc II Feb-06-2024
27 Getinge Usa Sales Inc I Jan-26-2023
28 Getinge Usa Sales Inc II Dec-07-2022
29 Getinge Usa Sales Inc I Jun-23-2022
30 Getinge Usa Sales Inc I Jan-10-2022
31 Mindray DS USA, Inc. dba Mindray North America II Nov-26-2025
32 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
33 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
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