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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
  1.  K230931  Atlan
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2687 2688
2021 3123 3124
2022 4352 4355
2023 5595 5596
2024 6067 6067
2025 9365 9365
2026 561 561

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 5793 5793
Mechanical Problem 3749 3749
Failure to Run on Battery 3474 3474
No Flow 3135 3135
Insufficient Flow or Under Infusion 2087 2087
No Display/Image 1591 1591
Power Problem 1327 1327
Unexpected Therapeutic Results 1166 1166
Failure to Deliver 1135 1135
Electrical /Electronic Property Problem 1070 1070
Gas/Air Leak 1002 1003
Gas Output Problem 929 930
Output Problem 853 853
Increase in Pressure 781 781
Unexpected Shutdown 774 774
Infusion or Flow Problem 551 551
Failure to Power Up 410 410
Inaccurate Delivery 405 405
Pressure Problem 264 264
Suction Failure 223 223
Intermittent Continuity 217 217
Physical Resistance/Sticking 216 216
Insufficient Information 204 204
Improper Flow or Infusion 197 197
Decrease in Suction 197 197
No Visual Prompts/Feedback 187 187
Leak/Splash 174 174
No Apparent Adverse Event 164 164
Inappropriate or Unexpected Reset 160 160
Decrease in Pressure 159 159
Intermittent Communication Failure 154 154
Break 147 147
Complete Loss of Power 138 138
Detachment of Device or Device Component 131 131
No Audible Alarm 126 126
Failure to Analyze Signal 92 92
No Pressure 91 91
Protective Measures Problem 87 87
Adverse Event Without Identified Device or Use Problem 84 85
Battery Problem 83 83
Use of Device Problem 79 82
Degraded 72 72
Excess Flow or Over-Infusion 60 60
Display or Visual Feedback Problem 56 56
Computer Software Problem 46 46
Output below Specifications 46 46
Circuit Failure 41 41
Failure to Sense 39 39
Device Displays Incorrect Message 35 35
Energy Output Problem 33 33

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28827 28829
No Patient Involvement 1166 1166
Insufficient Information 846 849
No Consequences Or Impact To Patient 632 633
Low Oxygen Saturation 125 125
No Known Impact Or Consequence To Patient 40 40
Cardiac Arrest 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Awareness during Anaesthesia 13 13
Vomiting 9 9
Loss of consciousness 8 8
Nausea 8 8
Hypoxia 8 8
Bradycardia 6 6
Burn(s) 6 6
Cyanosis 5 5
Airway Obstruction 5 5
Capsular Contracture 5 5
Low Blood Pressure/ Hypotension 4 4
Pneumothorax 4 4
Respiratory Arrest 4 4
No Information 4 4
Unspecified Respiratory Problem 4 4
Oversedation 4 4
Death 3 3
Apnea 3 3
Brain Injury 3 3
Tachycardia 3 3
Dizziness 3 3
Asystole 2 2
Laceration(s) 2 2
Cough 2 2
Cardiopulmonary Arrest 2 2
Bronchospasm 2 2
Chills 2 2
Convulsion/Seizure 2 2
Low Cardiac Output 2 2
Fecal Incontinence 2 2
Emotional Changes 2 2
Headache 2 2
Respiratory Insufficiency 2 2
Anxiety 1 1
Therapeutic Effects, Unexpected 1 1
Respiratory Distress Syndrome of Newborns 1 1
Pulmonary Edema 1 1
Ventilator Dependent 1 1
Lethargy 1 1
Coma 1 1
Overinflation of Lung 1 1
Dyspnea 1 1

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, Inc. I Oct-01-2025
7 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
8 GE Healthcare, LLC II Jul-20-2022
9 GE Healthcare, LLC I Jul-19-2022
10 GE Healthcare, LLC II Jun-24-2022
11 GE Healthcare, LLC II Sep-30-2021
12 GE Healthcare, LLC II Oct-30-2020
13 GE Healthcare, LLC I Jan-23-2020
14 GE Medical Systems China Co., Ltd. I Dec-18-2025
15 GE Medical Systems China Co., Ltd. I Apr-29-2025
16 Getinge Group Logistics America, LLC II Mar-05-2021
17 Getinge Usa Sales Inc I Feb-07-2025
18 Getinge Usa Sales Inc I May-31-2024
19 Getinge Usa Sales Inc II Feb-06-2024
20 Getinge Usa Sales Inc I Jan-26-2023
21 Getinge Usa Sales Inc II Dec-07-2022
22 Getinge Usa Sales Inc I Jun-23-2022
23 Getinge Usa Sales Inc I Jan-10-2022
24 Mindray DS USA, Inc. dba Mindray North America II Nov-26-2025
25 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
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