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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
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 4797 4797
Failure to Run on Battery 3527 3527
Mechanical Problem 3522 3522
No Flow 3412 3412
Insufficient Flow or Under Infusion 2163 2163
No Display/Image 1576 1576
Power Problem 1379 1379
Electrical /Electronic Property Problem 1138 1138
Unexpected Therapeutic Results 1107 1107
Failure to Deliver 989 989
Gas/Air Leak 851 852
Gas Output Problem 812 813
Output Problem 783 783
Unexpected Shutdown 673 673
Increase in Pressure 646 646
Infusion or Flow Problem 445 445
Failure to Power Up 418 418
Inaccurate Delivery 326 326
Pressure Problem 236 236
Improper Flow or Infusion 208 208
Insufficient Information 195 195
No Visual Prompts/Feedback 187 187
Leak/Splash 177 177
Intermittent Continuity 174 174
No Apparent Adverse Event 169 169
Suction Failure 153 153
Physical Resistance/Sticking 144 144
Decrease in Pressure 141 141
Complete Loss of Power 134 134
Intermittent Communication Failure 132 132
Inappropriate or Unexpected Reset 131 131
Decrease in Suction 127 127
No Audible Alarm 105 105
Detachment of Device or Device Component 104 104
Failure to Analyze Signal 86 86
Adverse Event Without Identified Device or Use Problem 83 84
Protective Measures Problem 79 79
Degraded 77 77
Battery Problem 76 76
Use of Device Problem 75 78
No Pressure 74 74
Break 69 69
Excess Flow or Over-Infusion 61 61
Display or Visual Feedback Problem 56 56
Output below Specifications 47 47
Computer Software Problem 42 42
Failure to Sense 37 37
Circuit Failure 35 35
Failure of Device to Self-Test 32 32
Device Displays Incorrect Message 31 31

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28780 28782
Insufficient Information 797 800
Low Oxygen Saturation 111 111
No Consequences Or Impact To Patient 42 42
Cardiac Arrest 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
No Patient Involvement 12 12
Vomiting 9 9
Loss of consciousness 8 8
Nausea 8 8
Awareness during Anaesthesia 7 7
Bradycardia 6 6
Burn(s) 6 6
Hypoxia 6 6
Airway Obstruction 5 5
Capsular Contracture 5 5
Low Blood Pressure/ Hypotension 4 4
Respiratory Arrest 4 4
Unspecified Respiratory Problem 4 4
Pneumothorax 3 3
Apnea 3 3
Cyanosis 3 3
Dizziness 3 3
Tachycardia 3 3
Brain Injury 3 3
Chills 2 2
Laceration(s) 2 2
Bronchospasm 2 2
Low Cardiac Output 2 2
Emotional Changes 2 2
Headache 2 2
Oversedation 2 2
Fecal Incontinence 2 2
Respiratory Insufficiency 2 2
Asystole 2 2
Cough 2 2
Convulsion/Seizure 2 2
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Blood or Lymphatic problem 1 1
Superficial (First Degree) Burn 1 1
Urinary Incontinence 1 1
Metal Related Pathology 1 1
Solid Tumour 1 1
Pulmonary Edema 1 1
Respiratory Distress Syndrome of Newborns 1 1
Failure of Implant 1 1
High Blood Pressure/ Hypertension 1 1
Dyspnea 1 1
Arrhythmia 1 1
Electric Shock 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 Medical Systems China Co., Ltd. I Dec-18-2025
13 GE Medical Systems China Co., Ltd. I Apr-29-2025
14 Getinge Group Logistics America, LLC II Mar-05-2021
15 Getinge Usa Sales Inc I Feb-07-2025
16 Getinge Usa Sales Inc I May-31-2024
17 Getinge Usa Sales Inc II Feb-06-2024
18 Getinge Usa Sales Inc I Jan-26-2023
19 Getinge Usa Sales Inc II Dec-07-2022
20 Getinge Usa Sales Inc I Jun-23-2022
21 Getinge Usa Sales Inc I Jan-10-2022
22 Mindray DS USA, Inc. dba Mindray North America II Nov-26-2025
23 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
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