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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 2
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K171292  A7 Anesthesia System
  2.  K171311  A5 Anesthesia System
  3.  K201957  A8, A9 Anesthesia System
  4.  K253330  A5 Anesthesia System (A5); A7 Anesthesia System (A ...

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 4904 4904

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 6902 7097
Mechanical Problem 4502 4530
No Flow 4181 4181
Failure to Run on Battery 3959 3959
Insufficient Flow or Under Infusion 2506 2506
Power Problem 1627 1627
No Display/Image 1623 1623
Unexpected Therapeutic Results 1430 1433
Electrical /Electronic Property Problem 1394 1394
Failure to Deliver 1287 1287
Gas/Air Leak 1284 1316
Output Problem 1254 1254
Gas Output Problem 1084 1085
Increase in Pressure 989 1003
Unexpected Shutdown 929 934
Infusion or Flow Problem 744 754
Failure to Power Up 512 512
Inaccurate Delivery 490 492
Appropriate Device Problem Term/Code Not Available 367 367
Pressure Problem 353 357
Physical Resistance/Sticking 318 323
Leak/Splash 305 305
Suction Failure 289 293
Break 287 291
Improper Flow or Infusion 270 270
Decrease in Suction 251 260
Intermittent Continuity 232 232
Inappropriate or Unexpected Reset 223 224
Insufficient Device Problem Information 223 223
Decrease in Pressure 203 203
Device Alarm System 195 195
No Apparent Adverse Event 194 194
Device Operates Differently Than Expected 188 188
No Visual Prompts/Feedback 187 187
Intermittent Communication Failure 186 186
Detachment of Device or Device Component 173 173
No Pressure 155 155
Complete Loss of Power 151 151
Device Displays Incorrect Message 145 145
Energy Output Problem 144 146
No Audible Alarm 139 140
Mechanical Jam 106 106
Excess Flow or Over-Infusion 106 106
Suction Problem 102 102
Battery Problem 101 101
Failure to Analyze Signal 100 100
Adverse Event Without Identified Device or Use Problem 92 93
Protective Measures Problem 91 91
Degraded 88 88
Use of Device Problem 82 82

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33123 33125
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1926
Insufficient Information 853 856
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 160 160
Cardiac Arrest 43 43
Hypoxia 33 33
Awareness during Anaesthesia 24 24
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 23 23
Hypoventilation 23 27
Distress 20 20
Death 18 18
Patient Problem/Medical Problem 15 15
No Information 13 14
Burn(s) 11 11
Cyanosis 9 9
Nausea 9 9
Vomiting 9 9
Loss of consciousness 9 9
Bradycardia 7 7
Pneumothorax 7 7
Brain Injury 6 6
Capsular Contracture 5 5
No Code Available 5 5
Respiratory Arrest 5 5
Low Blood Pressure/ Hypotension 5 5
Airway Obstruction 5 5
Tachycardia 4 4
Unspecified Respiratory Problem 4 4
Oversedation 4 4
Dizziness 4 4
Therapeutic Effects, Unexpected 3 5
Respiratory Distress 3 3
Emotional Changes 3 3
Cardiopulmonary Arrest 3 3
Apnea 3 3
Respiratory Insufficiency 2 2
Low Cardiac Output 2 2
Headache 2 2
Fecal Incontinence 2 2
Chills 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Urinary Retention 2 2
Convulsion/Seizure 2 2
Partial thickness (Second Degree) Burn 2 2
Laceration(s) 2 2
Coma 2 2
Asystole 2 2
Cough 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 Jun-04-2026
9 Draeger, Inc. I Oct-01-2025
10 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
11 GE Healthcare, LLC II Jul-20-2022
12 GE Healthcare, LLC I Jul-19-2022
13 GE Healthcare, LLC II Jun-24-2022
14 GE Healthcare, LLC II Sep-30-2021
15 GE Healthcare, LLC II Oct-30-2020
16 GE Healthcare, LLC I Jan-23-2020
17 GE Healthcare, LLC II Dec-17-2019
18 GE Healthcare, LLC II Nov-09-2018
19 GE Healthcare, LLC II Mar-26-2018
20 GE Medical Systems China Co., Ltd. I Dec-18-2025
21 GE Medical Systems China Co., Ltd. I Apr-29-2025
22 GE Medical Systems China Co., Ltd. II Aug-30-2018
23 GE Medical Systems China Co., Ltd. II Feb-09-2018
24 Getinge Group Logistics America, LLC II Mar-05-2021
25 Getinge Usa Sales Inc I Feb-07-2025
26 Getinge Usa Sales Inc I May-31-2024
27 Getinge Usa Sales Inc II Feb-06-2024
28 Getinge Usa Sales Inc I Jan-26-2023
29 Getinge Usa Sales Inc II Dec-07-2022
30 Getinge Usa Sales Inc I Jun-23-2022
31 Getinge Usa Sales Inc I Jan-10-2022
32 Maquet Critical Care AB II Aug-03-2026
33 Mindray DS USA, Inc. dba Mindray North America II Nov-26-2025
34 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
35 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
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