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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
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
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 5228 5228
No Flow 4162 4162
Failure to Run on Battery 3936 3936
Mechanical Problem 3785 3785
Insufficient Flow or Under Infusion 2504 2504
Power Problem 1622 1622
No Display/Image 1573 1573
Electrical /Electronic Property Problem 1386 1386
Unexpected Therapeutic Results 1230 1230
Failure to Deliver 1063 1063
Gas/Air Leak 919 919
Gas Output Problem 907 908
Output Problem 818 818
Unexpected Shutdown 736 736
Increase in Pressure 734 734
Failure to Power Up 510 510
Infusion or Flow Problem 472 472
Inaccurate Delivery 343 343
Improper Flow or Infusion 258 258
Pressure Problem 238 238
Leak/Splash 208 208
Insufficient Device Problem Information 208 208
No Apparent Adverse Event 194 194
No Visual Prompts/Feedback 187 187
Intermittent Continuity 182 182
Decrease in Pressure 174 174
Intermittent Communication Failure 158 158
Suction Failure 152 152
Physical Resistance/Sticking 147 147
Inappropriate or Unexpected Reset 146 146
Complete Loss of Power 145 145
Decrease in Suction 127 127
Detachment of Device or Device Component 107 107
No Audible Alarm 104 104
Failure to Analyze Signal 91 91
Degraded 87 87
Adverse Event Without Identified Device or Use Problem 86 87
No Pressure 80 80
Protective Measures Problem 80 80
Battery Problem 80 80
Use of Device Problem 74 74
Excess Flow or Over-Infusion 70 70
Break 69 69
Output below Specifications 62 62
Circuit Failure 58 58
Failure of Device to Self-Test 55 55
Computer Software Problem 47 47
Display or Visual Feedback Problem 43 43
Failure to Sense 39 39
Device Sensing Problem 32 32

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32281 32283
Insufficient Information 803 806
Low Oxygen Saturation 123 123
No Consequences Or Impact To Patient 42 42
Cardiac Arrest 34 34
Hypoxia 28 28
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 22 22
Distress 20 20
Hypoventilation 20 20
No Patient Involvement 12 12
Nausea 9 9
Vomiting 9 9
Loss of consciousness 8 8
Burn(s) 7 7
Awareness during Anaesthesia 7 7
Bradycardia 6 6
Airway Obstruction 5 5
Respiratory Arrest 5 5
Capsular Contracture 5 5
Pneumothorax 4 4
Low Blood Pressure/ Hypotension 4 4
Dizziness 4 4
Unspecified Respiratory Problem 4 4
Cyanosis 3 3
Apnea 3 3
Emotional Changes 3 3
Brain Injury 3 3
Tachycardia 3 3
Respiratory Insufficiency 2 2
Headache 2 2
Convulsion/Seizure 2 2
Cough 2 2
Bronchospasm 2 2
Asystole 2 2
Laceration(s) 2 2
Chills 2 2
Oversedation 2 2
Low Cardiac Output 2 2
Fecal Incontinence 2 2
Dyspnea 1 1
Overinflation of Lung 1 1
Coma 1 1
Bone Cement Implantation Syndrome 1 1
Sleepiness/Drowsiness/Somnolence 1 1
Concussion 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Blood or Lymphatic problem 1 1
Pulmonary Edema 1 1
Anxiety 1 1
Respiratory Acidosis 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 Jun-04-2026
7 Draeger, Inc. I Oct-01-2025
8 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
9 GE Healthcare, LLC II Jul-20-2022
10 GE Healthcare, LLC I Jul-19-2022
11 GE Healthcare, LLC II Jun-24-2022
12 GE Healthcare, LLC II Sep-30-2021
13 GE Medical Systems China Co., Ltd. I Dec-18-2025
14 GE Medical Systems China Co., Ltd. I Apr-29-2025
15 Getinge Group Logistics America, LLC II Mar-05-2021
16 Getinge Usa Sales Inc I Feb-07-2025
17 Getinge Usa Sales Inc I May-31-2024
18 Getinge Usa Sales Inc II Feb-06-2024
19 Getinge Usa Sales Inc I Jan-26-2023
20 Getinge Usa Sales Inc II Dec-07-2022
21 Getinge Usa Sales Inc I Jun-23-2022
22 Getinge Usa Sales Inc I Jan-10-2022
23 Maquet Critical Care AB II Aug-03-2026
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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