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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 4217 4217

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 5114 5114
No Flow 4116 4116
Failure to Run on Battery 3845 3845
Mechanical Problem 3714 3714
Insufficient Flow or Under Infusion 2436 2436
Power Problem 1580 1580
No Display/Image 1573 1573
Electrical /Electronic Property Problem 1333 1333
Unexpected Therapeutic Results 1197 1197
Failure to Deliver 1044 1044
Gas/Air Leak 907 907
Gas Output Problem 895 896
Output Problem 811 811
Unexpected Shutdown 717 717
Increase in Pressure 713 713
Failure to Power Up 480 480
Infusion or Flow Problem 465 465
Inaccurate Delivery 341 341
Improper Flow or Infusion 240 240
Pressure Problem 237 237
Insufficient Device Problem Information 205 205
Leak/Splash 201 201
No Apparent Adverse Event 191 191
No Visual Prompts/Feedback 187 187
Intermittent Continuity 181 181
Decrease in Pressure 171 171
Suction Failure 152 152
Intermittent Communication Failure 152 152
Physical Resistance/Sticking 146 146
Inappropriate or Unexpected Reset 143 143
Complete Loss of Power 142 142
Decrease in Suction 127 127
Detachment of Device or Device Component 106 106
No Audible Alarm 104 104
Failure to Analyze Signal 90 90
Adverse Event Without Identified Device or Use Problem 86 87
Degraded 85 85
Protective Measures Problem 79 79
No Pressure 78 78
Battery Problem 76 76
Use of Device Problem 71 71
Break 69 69
Excess Flow or Over-Infusion 69 69
Output below Specifications 58 58
Circuit Failure 58 58
Failure of Device to Self-Test 45 45
Computer Software Problem 44 44
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 31601 31603
Insufficient Information 801 804
Low Oxygen Saturation 120 120
No Consequences Or Impact To Patient 42 42
Cardiac Arrest 33 33
Hypoxia 27 27
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 22 22
Distress 20 20
Hypoventilation 20 20
No Patient Involvement 12 12
Vomiting 9 9
Nausea 9 9
Loss of consciousness 8 8
Burn(s) 7 7
Awareness during Anaesthesia 7 7
Bradycardia 6 6
Capsular Contracture 5 5
Airway Obstruction 5 5
Respiratory Arrest 5 5
Low Blood Pressure/ Hypotension 4 4
Unspecified Respiratory Problem 4 4
Pneumothorax 4 4
Dizziness 4 4
Cyanosis 3 3
Apnea 3 3
Tachycardia 3 3
Brain Injury 3 3
Emotional Changes 3 3
Low Cardiac Output 2 2
Convulsion/Seizure 2 2
Respiratory Insufficiency 2 2
Laceration(s) 2 2
Bronchospasm 2 2
Asystole 2 2
Oversedation 2 2
Cough 2 2
Headache 2 2
Chills 2 2
Fecal Incontinence 2 2
Respiratory Failure 1 1
Arrhythmia 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Respiratory Distress Syndrome of Newborns 1 1
Electric Shock 1 1
Urinary Incontinence 1 1
Unspecified Blood or Lymphatic problem 1 1
Concussion 1 1
Dyspnea 1 1
Anxiety 1 1
High Blood Pressure/ Hypertension 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 Mindray DS USA, Inc. dba Mindray North America II Nov-26-2025
24 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
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