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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
  1.  K251352  Codonics Safe Labeling System-Point of Care Statio ...
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

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 4217 4217

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 6788 6983
Mechanical Problem 4431 4459
No Flow 4135 4135
Failure to Run on Battery 3868 3868
Insufficient Flow or Under Infusion 2438 2438
No Display/Image 1623 1623
Power Problem 1585 1585
Unexpected Therapeutic Results 1397 1400
Electrical /Electronic Property Problem 1341 1341
Gas/Air Leak 1272 1304
Failure to Deliver 1268 1268
Output Problem 1247 1247
Gas Output Problem 1072 1073
Increase in Pressure 968 982
Unexpected Shutdown 910 915
Infusion or Flow Problem 737 747
Inaccurate Delivery 488 490
Failure to Power Up 482 482
Appropriate Device Problem Term/Code Not Available 367 367
Pressure Problem 352 356
Physical Resistance/Sticking 317 322
Leak/Splash 298 298
Suction Failure 289 293
Break 287 291
Improper Flow or Infusion 252 252
Decrease in Suction 251 260
Intermittent Continuity 231 231
Insufficient Device Problem Information 220 220
Inappropriate or Unexpected Reset 220 221
Decrease in Pressure 200 200
Device Alarm System 194 194
No Apparent Adverse Event 191 191
Device Operates Differently Than Expected 188 188
No Visual Prompts/Feedback 187 187
Intermittent Communication Failure 180 180
Detachment of Device or Device Component 172 172
No Pressure 153 153
Complete Loss of Power 148 148
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 105 105
Suction Problem 102 102
Failure to Analyze Signal 99 99
Battery Problem 97 97
Adverse Event Without Identified Device or Use Problem 92 93
Protective Measures Problem 90 90
Degraded 86 86
Use of Device Problem 79 79

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32443 32445
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1926
Insufficient Information 851 854
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 157 157
Cardiac Arrest 42 42
Hypoxia 32 32
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
Vomiting 9 9
Nausea 9 9
Loss of consciousness 9 9
Cyanosis 9 9
Pneumothorax 7 7
Bradycardia 7 7
Brain Injury 6 6
Low Blood Pressure/ Hypotension 5 5
Airway Obstruction 5 5
Capsular Contracture 5 5
Respiratory Arrest 5 5
No Code Available 5 5
Oversedation 4 4
Tachycardia 4 4
Dizziness 4 4
Unspecified Respiratory Problem 4 4
Apnea 3 3
Respiratory Distress 3 3
Cardiopulmonary Arrest 3 3
Emotional Changes 3 3
Therapeutic Effects, Unexpected 3 5
Respiratory Insufficiency 2 2
Convulsion/Seizure 2 2
Headache 2 2
Laceration(s) 2 2
Low Cardiac Output 2 2
Urinary Retention 2 2
Bronchospasm 2 2
Cough 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Chills 2 2
Partial thickness (Second Degree) Burn 2 2
Coma 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 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 Mindray DS USA, Inc. dba Mindray North America II Nov-26-2025
33 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
34 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
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