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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
  1.  K191027  Flow-i Anesthesia System, Flow-c Anesthesia System ...
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 9366 9366
2026 1352 1352

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 5870 5870
Mechanical Problem 3825 3825
Failure to Run on Battery 3534 3534
No Flow 3420 3420
Insufficient Flow or Under Infusion 2165 2165
No Display/Image 1592 1592
Power Problem 1380 1380
Unexpected Therapeutic Results 1184 1184
Failure to Deliver 1148 1148
Electrical /Electronic Property Problem 1139 1139
Gas/Air Leak 1015 1016
Gas Output Problem 942 943
Output Problem 856 856
Increase in Pressure 796 796
Unexpected Shutdown 778 778
Infusion or Flow Problem 558 558
Failure to Power Up 418 418
Inaccurate Delivery 409 409
Pressure Problem 268 268
Suction Failure 223 223
Intermittent Continuity 218 218
Physical Resistance/Sticking 216 216
Improper Flow or Infusion 213 213
Insufficient Information 209 209
Decrease in Suction 197 197
No Visual Prompts/Feedback 187 187
Leak/Splash 182 182
No Apparent Adverse Event 169 169
Inappropriate or Unexpected Reset 162 162
Decrease in Pressure 162 162
Intermittent Communication Failure 156 156
Break 147 147
Complete Loss of Power 138 138
Detachment of Device or Device Component 131 131
No Audible Alarm 126 126
No Pressure 94 94
Failure to Analyze Signal 92 92
Protective Measures Problem 89 89
Adverse Event Without Identified Device or Use Problem 86 87
Battery Problem 84 84
Use of Device Problem 79 82
Degraded 78 78
Excess Flow or Over-Infusion 61 61
Display or Visual Feedback Problem 56 56
Output below Specifications 47 47
Computer Software Problem 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 29616 29618
No Patient Involvement 1166 1166
Insufficient Information 847 850
No Consequences Or Impact To Patient 632 633
Low Oxygen Saturation 127 127
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
Nausea 8 8
Loss of consciousness 8 8
Hypoxia 8 8
Bradycardia 6 6
Burn(s) 6 6
Capsular Contracture 5 5
Cyanosis 5 5
Airway Obstruction 5 5
Low Blood Pressure/ Hypotension 4 4
Oversedation 4 4
Pneumothorax 4 4
No Information 4 4
Respiratory Arrest 4 4
Unspecified Respiratory Problem 4 4
Tachycardia 3 3
Dizziness 3 3
Brain Injury 3 3
Death 3 3
Apnea 3 3
Cardiopulmonary Arrest 2 2
Emotional Changes 2 2
Headache 2 2
Laceration(s) 2 2
Chills 2 2
Fecal Incontinence 2 2
Respiratory Insufficiency 2 2
Asystole 2 2
Cough 2 2
Convulsion/Seizure 2 2
Low Cardiac Output 2 2
Bronchospasm 2 2
Electric Shock 1 1
Lethargy 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Blood or Lymphatic problem 1 1
Urinary Incontinence 1 1
Metal Related Pathology 1 1
Solid Tumour 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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